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

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 st

Trial Details

NCT ID
NCT07213804
Phase
PHASE3
Sponsor
Eli Lilly and Company
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Sofetabart Mipitecan
  • Paclitaxel
  • Topotecan
  • Gemcitabine
  • Pegylated liposomal doxorubicin (PLD)
  • MIRV
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Burbank, California, United States|34.18084,-118.30897
  • La Jolla, California, United States|32.84727,-117.2742
  • Aurora, Colorado, United States|39.72943,-104.83192

Key Eligibility Criteria

  • 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

For full eligibility, visit ClinicalTrials.gov.

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