RecruitingHigh Grade Epithelial Ovarian CancerHigh Grade Serous Ovarian CancerPrimary Peritoneal Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

20 states

Healthy volunteers

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About this study

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).

Sponsor: Genmab

You may qualify if…

✓ 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, E, 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.

You may not qualify if…

✕ 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.