Sofetabart Mipitecan for Ovarian Cancer

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 Phase 3 Interventional Study
Ovarian Neoplasms Fallopian Tube Neoplasms Peritoneal Neoplasms Neoplasm Metastasis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,630 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for people with certain types of ovarian, fallopian tube, or peritoneal cancer. Participants will take a new treatment called Sofetabart Mipitecan to see if it works better than standard therapies.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have high-grade serous or endometrioid ovarian cancer.
  • I have a good performance status (ECOG 0-1).
  • I have measureable disease.
  • I have had my cancer progress on or after my last treatment.
  • I have tumor tissue available for testing.
  • I have received 1 to 3 prior lines of chemotherapy (4 lines if one includes mirvetuximab soravtansine).
  • I have previously taken bevacizumab unless I cannot.
  • If I have a BRCA mutation, I have been treated with a PARPi if needed.

You may not be able to join if

  • I have had cancer progression within the past month after first-line platinum chemotherapy.
  • I have received a prior antibody-drug conjugate with a topoisomerase inhibitor.
  • I have clinically significant proteinuria.
  • I have a known pathogenic BRCA1/2 gene alteration.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 pla…
Trial Locations
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Eligibility Criteria
Inclusion 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 anti…
Contacts

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT