Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)

Inclusion Criteria:

Part A and B:

• Histologically or cytologically confirmed metastatic or unresectable solidmalignancy including ovarian cancer (must have epithelial ovarian cancer, primaryperitoneal cancer, or fallopian tube cancer), endometrial cancer, non-small celllung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptorpositive, HER2-negative and triple-negative) (Part A), mesothelioma or cervicalcancer (Part B).

• Previously received therapies known to confer clinical benefit.

• Measurable disease per RECIST v1.1 for all tumor types other than pleuralmesothelioma which will use mRECIST v1.1 at baseline.

Part C and H:

Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.

• High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tubecancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, andthose with a sarcomatous or neuroendocrine element)

• Participants must have received up to 3 prior lines of therapy. Participants mayhave had up to to 4 prior lines of therapy are allowed if MIRV is locally approvedand was used as the last line of therapy. Participants must have progressedradiographically on or after their most recent line of therapy.

• Participants must have platinum-resistant ovarian cancer.

• Participants must have received prior bevacizumab or approved biosimilar.

• Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration [FDA]-approved test in a ClinicalLaboratory Improvement Amendments [CLIA]-certified laboratory; or locally approvedequivalent) and who achieved a complete or partial response to platinum-basedchemotherapy must have been treated with a poly ADP-ribose polymerase (PARP)inhibitor as maintenance treatment.

• Measurable disease per the RECIST v1.1 at baseline.

Part D:

Cohort D1:

• Participants must have platinum-sensitive ovarian cancer.

• Participants must have received 1 to 3 prior lines of therapy.

Cohort D2:

• Participants must have primary platinum-refractory, platinum-resistant, orplatinum-sensitive ovarian cancer.

• Participants with primary platinum-refractory ovarian cancer must have received ≤2prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as alack of response or by progression within 91 days after completing front-lineplatinum containing therapy.

• Participants must have received 1 to 3 prior lines of therapy for platinum-resistantovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitiveovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARPinhibitor, and MIRV.

• Participants with PSOC must have disease progression on or after maintenancetreatment, or at least 6 months (>183 days) or more from the last dose ofplatinum-based therapy.

Cohort D3 and D4:

• Endometrial cancer (any subtype excluding sarcoma).

Part F and G:

• Participants must have histologically or cytologically confirmed EC.

• Recurrent progressive EC (any subtype excluding neuroendocrine tumors,carcinosarcoma, or endometrial sarcoma) following prior therapy.

• Participants must have received 1 to 3 prior lines of therapy, and must haveprogressed radiographically on or after their most recent line of therapy:

• Participants must have received prior platinum-based chemotherapy and a programmeddeath-ligand 1 (PD-[L])1 inhibitor.

• Participants who progress >12 months after completion of prior adjuvant orneoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemictreatment prior to enrollment in this study.

• Hormonal therapy alone (i.e., without chemotherapy) will not be counted as aseparate line of therapy.

• Measurable disease per the RECIST Version 1.1 at baseline.

Part I:

• Participants must have histologically or cytologically confirmed high grade serousor endometrioid epithelial ovarian cancer, fallopian tube cancer and primaryperitoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixedtumors containing any of the above histologies or low grade/borderline ovariantumors).

• Participants must have platinum sensitive ovarian cancer.

• Measurable disease per the RECIST Version 1.1 at baseline.

Part J:

• Participants must have high grade epithelial ovarian cancer, primary peritonealcancer, or fallopian tube cancer including serous, endometrioid, and clear cellcarcinomas, and excluding mucinous, low grade, and those with a sarcomatous orneuroendocrine element.

• Measurable disease per the RECIST Version 1.1 at baseline.

Part K:

• Participants must have histologically or cytologically confirmed metastatic orunresectable ovarian cancer (must have high grade epithelial ovarian cancer, primaryperitoneal cancer, or fallopian tube cancer including serous, endometrioid, andclear cell carcinomas, and excluding mucinous, low grade, and those with asarcomatous or neuroendocrine element).

• Participants must have primary platinum-refractory, platinum-resistant, orplatinum-sensitive ovarian cancer.

• Measurable disease per the RECIST Version 1.1 at baseline.

Exclusion Criteria:

• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatrequired steroids within the past 2 years, has current ILD/pneumonitis, or wheresuspected ILD/pneumonitis cannot be ruled out by imaging at screening.

• Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.

Note: Other protocol-defined inclusion/exclusion may apply.