RecruitingOvarian NeoplasmsFallopian Tube NeoplasmsPeritoneal Neoplasms

A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer

Eligible age

18+ yrs

Accepts

All genders

Locations

34 states

Healthy volunteers

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About this study

This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.

Sponsor: Eli Lilly and Company

You may qualify if…

✓ Part A, B, and C:
✓ Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
✓ Have confirmed availability of tumor tissue block or slides
✓ Have radiographic progression on or after most recent line of systemic anticancer therapy
✓ Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓ Have measurable disease per RECIST v1.1
✓ Part A:
✓ Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.

You may not qualify if…

✕ Parts A, B and C:
✕ \- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.
✕ Part A:
✕ Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.
✕ Part B and C:
✕ \- Have clinically significant proteinuria
✕ Part C:
✕ \- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).