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Sofetabart Mipitecan for Ovarian, Fallopian Tube, or Peritoneal Cancer

This study is testing Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, fallopian tube, or peritoneal cancer. Sofe-M is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. The study has three parts: Part A is for those whose cancer has returned quickly after platinum-based chemotherapy (platinum-resistant), while Parts B and C are for those whose cancer responded well to platinum treatment (platinum-sensitive). Researchers want to see if Sofe-M works better than standard treatments like Paclitaxel, Topotecan, Gemcitabine, or Pegylated liposomal doxorubicin (PLD), and to understand its safety. You would need to have high-grade serous or endometrioid cancer and available tumor tissue. The study plans to enroll 1630 participants.

Study design
This is a three-part interventional study with a planned enrollment of 1630 participants. It compares Sofetabart Mipitecan to standard treatments.
What's involved
Your time in the study will depend on how you respond to the treatment. You will receive study drugs intravenously (IV).
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured from randomization to radiographic progression or death, for up to 70 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07213804

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
PHASE3Ages 18+InterventionalTreatment
Eli Lilly and Company
~1,630 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Sofetabart MipitecanPaclitaxelTopotecanGemcitabinePegylated liposomal doxorubicin (PLD)MIRV

At a glance

Recruiting sites
159 of 268 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator
Measured over Randomization to radiographic progression or death from any cause (up to 70 months)
+1 more outcome measured

Conditions

Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasm Metastasis

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Where it's being run

268 sites across 60 states
China23
Japan17
France12
Italy12
Ohio10
Australia10
Germany10
California9

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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.
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

Exclusion

Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.

What this trial measures

  • Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by InvestigatorRandomization to radiographic progression or death from any cause (up to 70 months)

    PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator

  • PFS per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded, Independent, Central Review (BICR)Randomization to radiographic progression or death from any cause (up to 70 months)