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

Recruiting now · Phase 3

Conditions studied: Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Neoplasm Metastasis

In brief

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.

Key facts

Study ID

NCT07213804

Run by

Eli Lilly and Company

People needed

1630

Starts

2025-10-22

Expected to finish

2031-08-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.
• Have received prior bevacizumab treatment, unless documented contraindication or intolerance.
• Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.
• Part B and C:
• Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (>)6 months of their last administration of platinum therapy
• Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy
• Part B:
• Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.
• Part C:
• Have not previously received a PARPi treatment.

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).

Where it is running

• Maine Medical Center - Scarborough Campus — Scarborough, Maine, United States (enrolling)
• Cox Medical Center North — Springfield, Missouri, United States (enrolling)
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States (enrolling)
• Trials 365 — Shreveport, Louisiana, United States (enrolling)
• West Michigan Cancer Center — Kalamazoo, Michigan, United States (enrolling)
• University of Missouri Hospital — Columbia, Missouri, United States (enrolling)
• UCLA Hematology/Oncology - Westwood (Building 100) — Los Angeles, California, United States (enrolling)
• HonorHealth — Phoenix, Arizona, United States (enrolling)
• Franciscan Health — Indianapolis, Indiana, United States (enrolling)
• Norton Women's and Children's Hospital — Louisville, Kentucky, United States (enrolling)
• Sinai Hospital Of Baltimore — Baltimore, Maryland, United States (enrolling)
• Karmanos Cancer Institute — Detroit, Michigan, United States (enrolling)
• Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center — Burbank, California, United States (enrolling)
• Broward Health Medical Center — Fort Lauderdale, Florida, United States (enrolling)
• Florida Cancer Specialist- South — Fort Myers, Florida, United States (enrolling)
• Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States (enrolling)
• Stanford Women's Cancer Center — Palo Alto, California, United States (enrolling)
• Mount Sinai Braman Comprehensive Cancer Center — Miami Beach, Florida, United States (enrolling)
• Sansum Clinic — Santa Barbara, California, United States (enrolling)
• OSF Saint Fracis Medical Center — Peoria, Illinois, United States (enrolling)
• Florida Cancer Specialist- East — West Palm Beach, Florida, United States (enrolling)
• Baptist Health Lexington — Lexington, Kentucky, United States (enrolling)
• Kaiser Permanente Zion Medical Center — Irvine, California, United States (enrolling)
• Greater Baltimore Medical Center — Baltimore, Maryland, United States (enrolling)
• The Center of Hope — Reno, Nevada, United States (enrolling)

Full record on ClinicalTrials.gov

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