MARKERS FOR USE IN METHODS FOR TREATING CANCERS WITH ANTIBODY DRUG CONJUGATES (ADC)

2023

Online Patent

Zugriff:

Diesen Eintrag von USPTO anschauen (Volltext)

Provided herein are methods for the treatment of cancers with antibody drug conjugates (ADC) using provided markers.

Titel:	MARKERS FOR USE IN METHODS FOR TREATING CANCERS WITH ANTIBODY DRUG CONJUGATES (ADC)
Link:	Diesen Eintrag von USPTO anschauen (Volltext)
Veröffentlichung:	2023
Medientyp:	Patent
Sonstiges:	Nachgewiesen in: USPTO Patent Applications Sprachen: English Document Number: 20230270871 Publication Date: August 31, 2023 Appl. No: 18/010970 Application Filed: June 18, 2021 Assignees: AGENSYS, INC. (Santa Monica, CA, US), SEAGEN INC. (Bothell, WA, US) Claim: 1. A method for treating cancer in a subject in need thereof comprising: (1) administering to the subject an antibody drug conjugate (ADC) comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) continue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) discontinue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more major histocompatibility complex (MHC) signature genes, one or more toll-like receptor (TLR) family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 2. A method for treating cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering a second dose of the ADC at the same or lower amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC at a higher amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 3. A method for treating cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor in conjunction with the administration of a second dose of the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 4. A method for treating cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor to the subject if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, wherein the checkpoint inhibitor in step (3)(a) is not administered in conjunction with the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 5. A method for inducing immunogenic cell death (ICD) in a cancer in a subject in need thereof comprising: (1) administering to the subject an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) continue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) discontinue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 6. A method for inducing ICD in a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering a second dose of the ADC at the same or lower amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, (b) or administering a second dose of the ADC at a higher amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 7. A method for inducing ICD in a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor in conjunction with the administration of a second dose of the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, (b) or administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 8. A method for inducing ICD in a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor to the subject if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, wherein the checkpoint inhibitor in step (3)(a) is not administered in conjunction with the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 9. A method for inducing immune cell migration to a cancer in a subject in need thereof comprising: (1) administering to the subject an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) continue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) discontinue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 10. A method for inducing immune cell migration to a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering a second dose of the ADC at the same or lower amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC at a higher amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 11. A method for inducing immune cell migration to a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor in conjunction with the administration of a second dose of the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 12. A method for inducing immune cell migration to a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of expression of one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor to the subject if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, wherein the checkpoint inhibitor in step (3)(a) is not administered in conjunction with the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 13. A method for increasing expression of one or more ADC Set I Marker genes in a cancer in a subject in need thereof comprising: (1) administering to the subject an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of the expression of the one or more ADC Set I Marker genes in the subject, and (3) (a) continue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) discontinue administering the ADC if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 14. A method for increasing expression of one or more ADC Set I Marker genes in a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of the expression of the one or more ADC Set I Marker genes in the subject, and (3) (a) administering a second dose of the ADC at the same or lower amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC at a higher amount than the first dose if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 15. A method for increasing expression of one or more ADC Set I Marker genes in a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of the expression of the one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor in conjunction with the administration of a second dose of the ADC if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 16. A method for increasing expression of one or more ADC Set I Marker genes in a cancer in a subject in need thereof comprising: (1) administering to the subject a first dose of an ADC comprising an antibody or antigen binding fragment thereof conjugated to one or more units of a cytotoxic agent via a linker, (2) determining an increase of the expression of the one or more ADC Set I Marker genes in the subject, and (3) (a) administering an immune checkpoint inhibitor to the subject if the expression of the one or more ADC Set I Marker genes in the subject is increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, or (b) administering a second dose of the ADC without the immune checkpoint inhibitor if the expression of the one or more ADC Set I Marker genes in the subject is not increased compared to the expression of the one or more ADC Set I Marker genes in the subject before the administration of the ADC, wherein the checkpoint inhibitor in step (3)(a) is not administered in conjunction with the ADC wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes, one or more TLR family genes, one or more interleukin receptor family genes, one or more immune checkpoint receptor genes, one or more receptor tyrosin kinase genes, one or more IFN receptor family genes, one or more TNF family receptor genes, one or more inhibitory immunoreceptor genes, and/or one or more metabolic enzyme genes. Claim: 17. The method of any one of claims 1 to 16, wherein the antibody or antigen binding fragment thereof is an anti-nectin-4 antibody or antigen binding fragment thereof. Claim: 18. The method of any one of claims 1 to 17, wherein the cytotoxic agent is a tubulin disrupting agent. Claim: 19. The method of claim 18, wherein the tubulin disrupting agent is selected from the group consisting of a dolastatin, an auristatin, a hemiasterlin, a vinca alkaloid, a maytansinoid, an eribulin, a colchicine, a plocabulin, a phomopsin, an epothilone, a cryptophycin, and a taxane. Claim: 20. The method of claim 18 or 19, wherein the tubulin disrupting agent is an auristatin. Claim: 21. The method of claim 19 or 20, wherein the auristatin is monomethyl auristatin E (MMAE), monomethyl auristatin F (MMAF), AFP, or auristain T. Claim: 22. The method of any one of claims 19 to 21, wherein the auristatin is MMAE. Claim: 23. The method of any one of claims 1 to 22, wherein the antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising complementarity determining region 1 (CDR-H1), CDR-H2, and CDR-H3 comprising the amino acid sequences of the corresponding CDR-H1, CDR-H2, and CDR-H3 in the heavy chain variable region sequence set forth in SEQ ID NO: 22 and a light chain variable region comprising CDR-L1, CDR-L2, and CDR-L3 comprising the amino acid sequences of the corresponding CDR-L1, CDR-L2, and CDR-L3 in the light chain variable region sequence set forth in SEQ ID NO: 23, and wherein the antibody or antigen binding fragment thereof is conjugated to 1 to 20 units of MMAE via a linker. Claim: 24. The method of any one of claims 1 to 23, wherein the one or more ADC Set I Marker genes comprise one or more MHC signature genes. Claim: 25. The method of any one of claims 1 to 23, wherein the one or more ADC Set I Marker genes consist of one or more MHC signature genes. Claim: 26. The method of any one of claims 1 to 25, wherein the one or more MHC signature genes comprise one or more MHC class genes. Claim: 27. The method of claim 26, wherein the one or more MHC class genes comprise one or more MHC class I genes. Claim: 28. The method of claim 27, wherein the one or more MHC class I genes comprise one or more genes selected from the group consisting of human leukocyte antigens-A (HLA-A), HLA-B, HLA-C, HLA-E, HLA-F, and Transporter 2, ATP binding cassette subfamily B member (TAP2). Claim: 29. The method of any one of claims 26 to 28, wherein the one or more MHC class genes comprise one or more MHC class II genes. Claim: 30. The method of claim 29, wherein the one or more MHC class II genes comprise one or more genes selected from the group consisting of HLA-DMA, HLA-DMB, HLA-DRB1, HLA-DRA, and HLA-DPA1. Claim: 31. The method of any one of claims 26 to 30, wherein the one or more MHC class genes or the one or more MHC class II genes do not comprise HLA-DPB1. Claim: 32. The method of any one of claims 26 to 30, wherein the MHC signature gene, the MHC class gene or the MHC class II gene is not HLA-DPB1. Claim: 33. The method of any one of claims 26 to 32, wherein the one or more MHC class genes comprise one or more MHC class III genes. Claim: 34. The method of claim 33, wherein the one or more MHC class III genes comprise one or more genes selected from the group consisting of LST1, LTB, AIF1, and TNF. Claim: 35. The method of any one of claims 1 to 34, wherein the one or more MHC signature genes comprise one or more MHC regulator genes. Claim: 36. The method of claim 35, wherein the one or more MHC regulator genes comprise one or more genes selected from the group consisting of interferon regulatory factor (IRF) genes, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) family genes, signal transducer and activator of transcription (STAT) family genes, CTCF, CIITA, RFX transcription factor family genes, SPI1, and nuclear transcription factor Y (NFY) genes. Claim: 37. The method of claim 36, wherein the NF-κB family genes comprise one or more genes selected from the group consisting of nuclear factor kappa B subunit 1 (NFKB1), NFKB2, RELA, RELB, and REL. Claim: 38. The method of claim 36 or 37, wherein the NF-κB family genes comprise NFKB2, RELA, or both NFKB2 and RELA. Claim: 39. The method of any one of claims 36 to 38, wherein the STAT family genes comprise one or more genes selected from the group consisting of STAT1, STAT2, STAT3, STAT4, STAT5, and STAT6. Claim: 40. The method of any one of claims 36 to 39, wherein the STAT family gene is STAT2. Claim: 41. The method of any one of claims 36 to 40, wherein the RFX transcription factor family genes comprise one or more genes selected from the group consisting of RFX1, RFX5, RFX7, RFXAP and RFXANK. Claim: 42. The method of any one of claims 36 to 41, wherein the IRF genes comprise IRF7, IRF8, or both IRF7 and IRF8. Claim: 43. The method of any one of claims 35 to 42, wherein the one or more MHC regulator genes comprise CTCF. Claim: 44. The method of any one of claims 35 to 43, wherein the one or more MHC regulator genes comprise CIITA. Claim: 45. The method of any one of claims 35 to 44, wherein the one or more MHC regulator genes comprise SPI1. Claim: 46. The method of any one of claims 36 to 45, wherein the NFY genes comprise NFYA, NFYC, or both NFYA and NFYC. Claim: 47. The method of any one of claims 1 to 46, wherein the one or more ADC Set I Marker genes comprise one or more TLR family genes. Claim: 48. The method of any one of claims 1 to 47, wherein the one or more TLR family genes comprise one or more genes selected from the group consisting of TLR9, TLR8, and TLR7. Claim: 49. The method of any one of claims 1 to 48, wherein the one or more TLR family genes do not comprise TLR3. Claim: 50. The method of any one of claims 1 to 49, wherein the one or more ADC Set I Marker genes comprise one or more interleukin receptor family genes. Claim: 51. The method of any one of claims 1 to 50, wherein the one or more interleukin receptor family genes comprise one or more genes selected from the group consisting of IL2RA, IL2RB, IL2RG, IL21R, IL27R, IL1RN, IL17RA, IL3RA, IL1R1, IL17RC, IL20RA, and IL22RA1. Claim: 52. The method of any one of claims 1 to 51, wherein the one or more interleukin receptor family genes comprise IL2RA. Claim: 53. The method of any one of claims 1 to 52, wherein the one or more interleukin receptor family genes consist of IL2RA. Claim: 54. The method of any one of claims 1 to 53, wherein the one or more ADC Set I Marker genes comprise one or more immune checkpoint receptor genes. Claim: 55. The method of any one of claims 1 to 54, wherein one or more immune checkpoint receptor genes comprise one or more B7 family genes, one or more Ig superfamily genes, or both one or more B7 family genes and one or more Ig superfamily genes. Claim: 56. The method of claim 55, wherein the B7 family genes comprise VTCN1, CD276, or both VTCN1 and CD276. Claim: 57. The method of claim 55 or 56, wherein the B7 family genes comprise VTCN1. Claim: 58. The method of any one of claims 55 to 57, wherein the B7 family genes consist of VTCN1. Claim: 59. The method of claim 55, wherein the Ig superfamily genes comprise nectin family genes. Claim: 60. The method of claim 55 or 59, wherein the Ig superfamily genes consist of nectin family genes. Claim: 61. The method of claim 55 or 59, wherein the Ig superfamily genes consist of LAG3 and nectin family genes. Claim: 62. The method of any one of claims 59 to 61, wherein the nectin family genes comprise one or more genes selected from the group consisting of PVRIG, PVRL2, and TIGIT. Claim: 63. The method of any one of claims 59 to 62, wherein the nectin family genes comprise TIGIT. Claim: 64. The method of any one of claims 59 to 63, wherein the nectin family genes consist of TIGIT. Claim: 65. The method of any one of claims 55 to 64, wherein the Ig superfamily genes comprise LAG3. Claim: 66. The method of any one of claims 55 to 58, wherein the Ig superfamily genes consist of LAG3. Claim: 67. The method of any one of claims 1 to 66, wherein the one or more ADC Set I Marker genes comprise one or more receptor tyrosin kinase genes. Claim: 68. The method of any one of claims 1 to 67, wherein the receptor tyrosin kinase genes comprise one or more genes selected from the group consisting of CSF1R, PDGFRB, TEK/TIE2, and FLT3. Claim: 69. The method of any one of claims 1 to 68, wherein the receptor tyrosin kinase genes consist of CSF1R. Claim: 70. The method of any one of claims 1 to 68, wherein the receptor tyrosin kinase genes comprise CSF1R. Claim: 71. The method of any one of claims 1 to 70, wherein the one or more ADC Set I Marker genes comprise one or more TNF family receptor genes. Claim: 72. The method of any one of claims 1 to 71, wherein the TNF family receptor genes comprise one or more genes selected from the group consisting of CD40, TNFRSF1A, TNFRSF21, and TNFRSF1B. Claim: 73. The method of any one of claims 1 to 72, wherein the one or more ADC Set I Marker genes comprise one or more IFN receptor family genes. Claim: 74. The method of any one of claims 1 to 73, wherein the IFN receptor family genes comprise IFNAR1, IFNAR2, or both IFNAR1 and IFNAR2. Claim: 75. The method of any one of claims 1 to 74, wherein the IFN receptor family genes consist of IFNAR1. Claim: 76. The method of any one of claims 1 to 74, wherein the IFN receptor family genes comprise IFNAR1. Claim: 77. The method of any one of claims 1 to 76, wherein the one or more ADC Set I Marker genes comprise one or more inhibitory immunoreceptor genes. Claim: 78. The method of any one of claims 1 to 77, wherein the inhibitory immunoreceptor genes comprise TIM3, VSIR, or both TIM3 and VSIR. Claim: 79. The method of any one of claims 1 to 78, wherein the inhibitory immunoreceptor genes comprise VSIR. Claim: 80. The method of any one of claims 1 to 78, wherein the inhibitory immunoreceptor genes consist of VSIR. Claim: 81. The method of any one of claims 1 to 79, wherein the inhibitory immunoreceptor genes comprise TIM3. Claim: 82. The method of any one of claims 1 to 78, wherein the inhibitory immunoreceptor genes consist of TIM3. Claim: 83. The method of any one of claims 1 to 82, wherein the one or more ADC Set I Marker genes comprise one or more metabolic enzyme genes. Claim: 84. The method of any one of claims 1 to 83, wherein the metabolic enzyme genes comprise one or more genes selected from the group consisting of indoleamine 2,3-dioxygenase 1 (IDO1), TDO2, EIF2AK2, ACSS1, and ACSS2. Claim: 85. The method of any one of claims 1 to 84, wherein the metabolic enzyme genes consist of IDO1. Claim: 86. The method of any one of claims 1 to 84, wherein the metabolic enzyme genes comprise IDO1. Claim: 87. The method of any one of claims 1 to 86, wherein the method further comprises determining an increase of expression of one or more ADC Set II Marker genes in the subject compared to the expression of the one or more ADC Set II Marker genes in the subject before the administration of the ADC in step (1). Claim: 88. The method of 87, wherein the administration in step (3)(a) is further conditioned on the increase of the expression of the one or more ADC Set II Marker genes as determined in claim 87. Claim: 89. The method of claim 87 or 88, wherein the one or more ADC Set II Marker genes comprise one or more genes selected from the group consisting of ER stress genes, ER/mitochondria ATPase genes, cell death genes, T cell stimulator genes, macrophage/innate immunity stimulator genes, chemoattractant genes, Rho GTPase genes, Rho GTPase regulator genes, mitotic arrest genes, siglec family genes, GO positive autophagy regulator genes, and GTPase related kinase genes. Claim: 90. The method of claim 89, wherein the ER stress genes comprise one or more genes selected from the group consisting of XBP-1S, ERP29, TRAF2, c-JUN, BCL2L11, BCAP31, SERINC3, DAP2IP, ERN1, ATF6, NCK2, PPP1R15A, UBQLN2, BAG6, and BOK. Claim: 91. The method of claim 89 or 90, wherein the ER stress genes do not comprise EDEM2 or XBP-1L. Claim: 92. The method of any one of claims 89 to 91, wherein the ER/mitochondria ATPase genes comprise one or more genes selected from the group consisting of ATP2A3, MT-ATP6, and MT-ATP8. Claim: 93. The method of any one of claims 89 to 92, wherein the cell death genes comprise one or more genes selected from the group consisting of Bax, BCL2L1, BCL2L11, and BOK. Claim: 94. The method of any one of claims 89 to 93, wherein the cell death genes do not comprise FAS. Claim: 95. The method of any one of claims 89 to 94, wherein the T cell stimulator genes comprise MIG (CXCL9), IP10 (CXCL10), or both MIG and IP10. Claim: 96. The method of any one of claims 89 to 95, wherein the macrophage/innate immunity stimulator genes comprise IL-1α, M-CSF (CSF), or both IL-1α and M-CSF. Claim: 97. The method of any one of claims 89 to 96, wherein the chemoattractant genes comprise one or more genes selected from the group consisting of Eotaxin (CCL11), MIP1α, MIP1β, and MCP1. Claim: 98. The method of any one of claims 89 to 97, wherein the Rho GTPase genes comprise one or more genes selected from the group consisting of RhoB, RhoF, and RhoG. Claim: 99. The method of any one of claims 89 to 98, wherein the Rho GTPase genes do not comprise any one of CDC42, RhoA, and RhoC. Claim: 100. The method of any one of claims 89 to 99, wherein the Rho GTPase regulator genes comprise one or more genes selected from the group consisting of DAP2IP, ARHGEF18, ARHGEF5, and RASAL1. Claim: 101. The method of any one of claims 89 to 100, wherein the mitotic arrest genes comprise one or more genes selected from the group consisting of CCND1, CDKN1A, GADD45B, E4F1, CDC14B, and DAPK1. Claim: 102. The method of any one of claims 89 to 101, wherein the mitotic arrest genes do not comprise DDIAS or CDK1. Claim: 103. The method of any one of claims 89 to 102, wherein the siglec family genes comprise siglec1. Claim: 104. The method of any one of claims 89 to 103, wherein the GO positive autophagy regulator genes comprise one or more genes selected from the group consisting of BCL2L11, ROCK1, TSC1, TSC2, BAG3, MFN2, RIPK1, RIPK4, HDAC6, STK11, ULK1, FOXO1, FOXO3, and MUL1. Claim: 105. The method of any one of claims 89 to 104, wherein the GO positive autophagy regulator genes do not comprise BNIP3 or BNIP3L. Claim: 106. The method of any one of claims 89 to 105, wherein the GTPase related kinase genes comprise ROCK1, PAK4, or both ROCK1 and PAK4. Claim: 107. The method of any one of claims 1 to 106, wherein the increase in any of the gene expression is an increase of 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%, 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, 200%, 250%, 300%, 350%, 400%, 450%, 500%, 550%, 600%, 650%, 700%, 750%, 800%, 850%, 900%, 950%, 1000%, or more. Claim: 108. The method of any one of claims 1 to 106, wherein the increase in any of the gene expression is an increase of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30 fold or more. Claim: 109. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 108, wherein the immune checkpoint inhibitor is a PD-1 inhibitor, a PD-L1 inhibitor, a PD-L2 inhibitor, a CTLA-4 inhibitor, a LAG-3 inhibitor, a B7 inhibitor, a TIM3 (HAVCR2) inhibitor, an OX40 (CD134) inhibitor, a GITR agonist, a CD137 agonist, a CD40 agonist, a VTCN1 inhibitor, an IDO1 inhibitor, a CD276 inhibitor, a PVRIG inhibitor, a TIGIT inhibitor, a CD25 (IL2RA) inhibitor, an IFNAR2 inhibitor, an IFNAR1 inhibitor, a CSF1R inhibitor, a VSIR (VISTA) inhibitor, or an therapeutic agent targeting HLA. Claim: 110. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is an anti-PD-1 antibody. Claim: 111. The method of claim 110, wherein the anti-PD-1 antibody is BGB-A317, nivolumab, pembrolizumab, cemiplimab, CT-011, camrelizumab, sintilimab, tislelizumab, TSR-042, PDR001, or toripalimab. Claim: 112. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is an anti-PD-L1 antibody. Claim: 113. The method of claim 112, wherein the anti-PD-L1 antibody is durvalumab, BMS-936559, atezolizumab, MEDI4736, or avelumab. Claim: 114. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is an anti-PD-L2 antibody. Claim: 115. The method of claim 114, wherein the anti-PD-L2 antibody is rHIgM12B7A. Claim: 116. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a VTCN1 inhibitor. Claim: 117. The method of claim 116, wherein the VTCN1 inhibitor is FPA150. Claim: 118. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is an IDO1 inhibitor. Claim: 119. The method of claim 118, wherein the IDO1 inhibitor is Epacadostat, BMS986205, Navoximod, PF-06840003, KHK2455, RG70099, IOM-E, or IOM-D. Claim: 120. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a TIGIT inhibitor. Claim: 121. The method of claim 120, wherein the a TIGIT inhibitor is MTIG7192A, BMS-986207, OMP-313M32, MK-7684, AB154, CGEN-15137, SEA-TIGIT, ASP8374, or AJUD008. Claim: 122. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a VSIR inhibitor. Claim: 123. The method of claim 122, wherein the VSIR inhibitor is CA-170, JNJ 61610588, or HMBD-002. Claim: 124. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a TIM3 inhibitor. Claim: 125. The method of claim 124, wherein the TIM3 inhibitor is AJUD009. Claim: 126. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a CD25 (IL2RA) inhibitor. Claim: 127. The method of claim 126, wherein the CD25 (IL2RA) inhibitor is daclizumab or basiliximab. Claim: 128. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is an IFNAR1 inhibitor. Claim: 129. The method of claim 128, wherein the IFNAR1 inhibitor is anifrolumab or sifalimumab. Claim: 130. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a CSF1R inhibitor. Claim: 131. The method of claim 130, wherein the CSF1R inhibitor is pexidartinib, emactuzumab, cabiralizumab, ARRY-382, BLZ945, AJUD010, AMG820, IMC-CS4, JNJ-40346527, PLX5622, or FPA008. Claim: 132. The method of any one of claims 3, 4, 7, 8, 11, 12, and 15 to 109, wherein the immune checkpoint inhibitor is a therapeutic agent targeting HLA. Claim: 133. The method of claim 132, wherein the therapeutic agent targeting HLA is GSK01, IMC-C103C, IMC-F106C, IMC-G107C, or ABBV-184. Claim: 134. The method of any one of claims 1 to 133, wherein the antibody or antigen binding fragment thereof comprises CDR-H1 comprising the amino acid sequence of SEQ ID NO:9, CDR-H2 comprising the amino acid sequence of SEQ ID NO:10, CDR-H3 comprising the amino acid sequence of SEQ ID NO:11; CDR-L1 comprising the amino acid sequence of SEQ ID NO:12, CDR-L2 comprising the amino acid sequence of SEQ ID NO:13, and CDR-L3 comprising the amino acid sequence of SEQ ID NO:14, or wherein the antibody or antigen binding fragment thereof comprises CDR-H1 comprising the amino acid sequence of SEQ ID NO:16, CDR-H2 comprising the amino acid sequence of SEQ ID NO:17, CDR-H3 comprising the amino acid sequence of SEQ ID NO:18; CDR-L1 comprising the amino acid sequence of SEQ ID NO:19, CDR-L2 comprising the amino acid sequence of SEQ ID NO:20, and CDR-L3 comprising the amino acid sequence of SEQ ID NO:21. Claim: 135. The method of any one of claims 1 to 134, wherein the antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO:22 and a light chain variable region comprising the amino acid sequence of SEQ ID NO:23. Claim: 136. The method of any one of claims 1 to 135, wherein the antibody comprises a heavy chain comprising the amino acid sequence ranging from the 20th amino acid (glutamic acid) to the 466th amino acid (lysine) of SEQ ID NO:7 and a light chain comprising the amino acid sequence ranging from the 23rd amino acid (aspartic acid) to the 236th amino acid (cysteine) of SEQ ID NO:8. Claim: 137. The method of any one of claims 1 to 136, wherein the antigen binding fragment is an Fab, F(ab′)2, Fv or scFv. Claim: 138. The method of any one of claims 1 to 137, wherein the antibody is a fully human antibody. Claim: 139. The method of any one of claims 1 to 138, wherein the antibody or antigen binding fragment thereof is recombinantly produced. Claim: 140. The method of any one of claims 1 to 139, wherein the ADC has the following structure: [chemical expression included] wherein L- represents the antibody or antigen binding fragment thereof and p is from 1 to 10. Claim: 141. The method of claim 140, wherein p is from 2 to 8. Claim: 142. The method of claim 140 or 141, wherein p is from 3 to 5. Claim: 143. The method of any one of claims 1 to 139, wherein the antibody or antigen binding fragment is conjugated to each unit of MMAE via a linker. Claim: 144. The method of claim 143, wherein the linker is an enzyme-cleavable linker, and wherein the linker forms a bond with a sulfur atom of the antibody or antigen binding fragment thereof. Claim: 145. The method of claim 143 or 144, wherein the linker has a formula of: -Aa-Ww-Yy-; wherein -A- is a stretcher unit, a is 0 or 1; -W- is an amino acid unit, w is an integer ranging from 0 to 12; and -Y- is a spacer unit, y is 0, 1, or 2. Claim: 146. The method of claim 145, wherein the stretcher unit has the structure of Formula (1) below; the amino acid unit is valine-citrulline; and the spacer unit is a PAB group comprising the structure of Formula (2) below: [chemical expression included] Claim: 147. The method of claim 145 or 146, wherein the stretcher unit forms a bond with a sulfur atom of the antibody or antigen binding fragment thereof; and wherein the spacer unit is linked to MMAE via a carbamate group. Claim: 148. The method of any one of claims 1 to 139 and 143 to 147, wherein the ADC comprises from 1 to 20 units of MMAE per antibody or antigen binding fragment thereof. Claim: 149. The method of any one of claims 1 to 139 and 143 to 148, wherein the ADC comprises from 1 to 10 units of MMAE per antibody or antigen binding fragment thereof. Claim: 150. The method of any one of claims 1 to 139 and 143 to 149, wherein the ADC comprises from 2 to 8 units of MMAE per antibody or antigen binding fragment thereof. Claim: 151. The method of any one of claims 1 to 139 and 143 to 150, wherein the ADC comprises from 3 to 5 units of MMAE per antibody or antigen binding fragment thereof. Claim: 152. The method of any one of claims 1, 5, 9, 13, and 17 to 151, wherein the ADC is administered at a dose of about 1 to about 10 mg/kg of the subject's body weight, about 1 to about 5 mg/kg of the subject's body weight, about 1 to about 2.5 mg/kg of the subject's body weight, or about 1 to about 1.25 mg/kg of the subject's body weight. Claim: 153. The method of any one of claims 1, 5, 9, 13, and 17 to 152, wherein the ADC is administered at a dose of about 0.25 mg/kg, about 0.5 mg/kg, about 0.75 mg/kg, about 1.0 mg/kg, about 1.25 mg/kg, about 1.5 mg/kg, about 1.75 mg/kg, about 2.0 mg/kg, about 2.25 mg/kg, or about 2.5 mg/kg of the subject's body weight. Claim: 154. The method of any one of claims 1, 5, 9, 13, and 17 to 153, wherein the ADC is administered at a dose of about 1 mg/kg of the subject's body weight. Claim: 155. The method of any one of claims 1, 5, 9, 13, and 17 to 153, wherein the ADC is administered at a dose of about 1.25 mg/kg of the subject's body weight. Claim: 156. The method of any one of claims 2 to 4, 6 to 8, 10 to 12, 14 to 151, wherein the first dose of the ADC is a dose of about 1 to about 10 mg/kg of the subject's body weight, about 1 to about 5 mg/kg of the subject's body weight, about 1 to about 2.5 mg/kg of the subject's body weight, or about 1 to about 1.25 mg/kg of the subject's body weight. Claim: 157. The method of claim 156, wherein the first dose of the ADC is a dose of about 0.5 mg/kg, about 0.75 mg/kg, about 1.0 mg/kg, about 1.25 mg/kg, about 1.5 mg/kg, about 1.75 mg/kg, about 2.0 mg/kg, about 2.25 mg/kg, or about 2.5 mg/kg of the subject's body weight. Claim: 158. The method of claim 156 or 157, wherein the first dose of ADC is a dose of about 1 mg/kg of the subject's body weight. Claim: 159. The method of claim 156 or 157, wherein the first dose of ADC is a dose of about 1.25 mg/kg of the subject's body weight. Claim: 160. The method of any one of claims 156 to 159, wherein the second dose of the ADC is lower than the first dose by about 0.1 mg/kg to about 1 mg/kg of the subject's body weight. Claim: 161. The method of any one of claims 156 to 160, wherein the second dose of the ADC is lower than the first dose by about 0.1 mg/kg, about 0.2 mg/kg, about 0.25 mg/kg, about 0.3 mg/kg, about 0.4 mg/kg, about 0.5 mg/kg, about 0.6 mg/kg, about 0.7 mg/kg, about 0.75 mg/kg, about 0.8 mg/kg, about 0.9 mg/kg, or about 1 mg/kg of the subject's body weight. Claim: 162. The method of any one of claims 156 to 161, wherein the second dose of the ADC is lower than the first dose by about 0.25 mg/kg of the subject's body weight. Claim: 163. The method of any one of claims 156 to 161, wherein the second dose of the ADC is lower than the first dose by about 0.5 mg/kg of the subject's body weight. Claim: 164. The method of any one of claims 156 to 161, wherein the second dose of the ADC is lower than the first dose by about 0.75 mg/kg of the subject's body weight. Claim: 165. The method of any one of claims 156 to 161, wherein the second dose of the ADC is lower than the first dose by about 1.0 mg/kg of the subject's body weight. Claim: 166. The method of any one of claims 156 to 165, wherein the second dose of the ADC is a dose of about 0.25 mg/kg, about 0.5 mg/kg, about 0.75 mg/kg, about 1.0 mg/kg, about 1.25 mg/kg, about 1.5 mg/kg, about 1.75 mg/kg, about 2.0 mg/kg, or about 2.25 mg/kg of the subject's body weight. Claim: 167. The method of any one of claims 156 to 166, wherein the second dose of the ADC is identical to the first dose of the ADC. Claim: 168. The method of any one of claims 1 to 166, wherein the ADC is administered by an intravenous (IV) injection or infusion. Claim: 169. The method of any one of claims 1 to 168, wherein the ADC is administered by an IV injection or infusion three times every four-week cycle. Claim: 170. The method of any one of claims 1 to 169, wherein the ADC is administered by an IV injection or infusion on Days 1, 8 and 15 of every four-week cycle. Claim: 171. The method of any one of claims 1 to 170, wherein the ADC is administered by an IV injection or infusion over about 30 minutes three times every four-week cycle. Claim: 172. The method of any one of claims 1 to 171, wherein the ADC is administered by an IV injection or infusion over about 30 minutes on Days 1, 8 and 15 of every four-week cycle. Claim: 173. The method of any one of claims 1 to 172, wherein the ADC is formulated in a pharmaceutical composition comprising L-histidine, polysorbate-20 (TWEEN-20), and trehalose dehydrate. Claim: 174. The method of any one of claims 1 to 173, wherein the ADC is formulated in a pharmaceutical composition comprising about 20 mM L-histidine, about 0.02% (w/v) TWEEN-20, about 5.5% (w/v) trehalose dihydrate, and hydrochloride, and wherein the pH of the pharmaceutical composition is about 6.0 at 25° C. Claim: 175. The method of any one of claims 1 to 173, wherein the ADC is formulated in a pharmaceutical composition comprising about 9 mM histidine, about 11 mM histidine hydrochloride monohydrate, about 0.02% (w/v) TWEEN-20, and about 5.5% (w/v) trehalose dihydrate, and wherein the pH of the pharmaceutical composition is about 6.0 at 25° C. Claim: 176. The method of any one of claims 1 to 175, wherein the cancer is bladder cancer, urothelial cancer, gastric cancer, esophageal cancer, head cancer, neck cancer, squamous non-small cell lung cancer (NSCLC), non-squamous NSCLC, breast cancer, ovarian cancer, cervical cancer, biliary cancer and cholangiocarcinomas, pancreatic cancer, squamous cell carcinoma of the vulva and penis, prostate adenocarcinoma, or endometrial carcinoma. Claim: 177. The method of any one of claims 1 to 176, wherein the cancer is locally advanced cancer. Claim: 178. The method of any one of claims 1 to 176, wherein the cancer is metastatic cancer. Claim: 179. The method of any one of claims 176 to 178, wherein the breast cancer is ER negative, PR negative, and HER2 negative (ER−/PR−/HER2−) breast cancer. Claim: 180. The method of any one of claims 176 to 179, wherein the breast cancer is hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2−) breast cancer. Claim: 181. The method of any one of claims 176 to 178, wherein the urothelial cancer is papillary urothelial carcinoma or flat urothelial carcinoma. Claim: 182. The method of any one of claims 176 to 178, wherein the bladder cancer is non-muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer. Claim: 183. The method of claim 182, wherein the muscle-invasive bladder cancer is squamous cell carcinoma, adenocarcinoma, small cell carcinoma, or sarcoma. Current International Class: 61; 07; 61; 61

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