Phase 1/2 Study of Rina-S in Patients with Locally Advanced and/or Metastatic Solid Tumors

This study will test the safety, including side effects, and determine the
characteristics of a drug called Rina-S in participants with solid tumors.

Participants will have solid tumor cancer that has spread through the body (metastatic)
or cannot be removed with surgery (unresectable).

Inclusion Criteria:

Part A and B:

- Histologically or cytologically confirmed metastatic or unresectable solid
malignancy including ovarian cancer (must have epithelial ovarian cancer, primary
peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell
lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor
positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical
cancer (Part B).

- Previously received therapies known to confer clinical benefit.

- Measurable disease per RECIST v1.1 for all tumor types other than pleural
mesothelioma 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 tube
cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and
those with a sarcomatous or neuroendocrine element)

- Participants must have received up to 3 prior lines of therapy. Participants may
have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved
and was used as the last line of therapy. Participants must have progressed
radiographically 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 Clinical
Laboratory Improvement Amendments [CLIA]-certified laboratory; or locally approved
equivalent) and who achieved a complete or partial response to platinum-based
chemotherapy 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, or
platinum-sensitive ovarian cancer.

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

- Participants must have received 1 to 3 prior lines of therapy for platinum-resistant
ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive
ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP
inhibitor, and MIRV.

- Participants with PSOC must have disease progression on or after maintenance
treatment, or at least 6 months (>183 days) or more from the last dose of
platinum-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 have
progressed radiographically on or after their most recent line of therapy:

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

- Participants who progress >12 months after completion of prior adjuvant or
neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic
treatment prior to enrollment in this study.

- Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a
separate line of therapy.

- Measurable disease per the RECIST Version 1.1 at baseline.

Part I:

- Participants must have histologically or cytologically confirmed high grade serous
or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary
peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed
tumors containing any of the above histologies or low grade/borderline ovarian
tumors).

- 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 peritoneal
cancer, or fallopian tube cancer including serous, endometrioid, and clear cell
carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or
neuroendocrine element.

- Measurable disease per the RECIST Version 1.1 at baseline.

Part K:

- Participants must have histologically or cytologically confirmed metastatic or
unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary
peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and
clear cell carcinomas, and excluding mucinous, low grade, and those with a
sarcomatous or neuroendocrine element).

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

- Measurable disease per the RECIST Version 1.1 at baseline.

Exclusion Criteria:

- History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that
required steroids within the past 2 years, has current ILD/pneumonitis, or where
suspected 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.