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Sofetabart Mipitecan (LY4170156) versus standard chemotherapy for platinum-resistant and platinum-sensitive high-grade ovarian, fallopian tube, and primary peritoneal cancer

FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) Versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan Plus Bevacizumab Versus Platinum-Based Chemotherapy Plus Bevacizumab in Platinum-Sensitive Ovarian Cancer.

Phase 3 Interventional Eli Lilly and Company · NCT07213804

This trial tests whether the targeted drug Sofetabart Mipitecan can better shrink tumors or delay progression than standard chemotherapies for people with platinum-resistant or platinum-sensitive high-grade ovarian, fallopian tube, or primary peritoneal cancer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1080 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionsmirvetuximab, bevacizumab, chemotherapy
Locations260 sites (Birmingham, Alabama and 259 other locations)
Trial IDNCT07213804 on ClinicalTrials.gov

What this trial studies

This two-part Phase 3 trial separates participants into platinum-resistant (Part A) and platinum-sensitive (Part B) cohorts and compares Sofetabart Mipitecan to commonly used chemotherapies including paclitaxel, topotecan, gemcitabine, and pegylated liposomal doxorubicin. Eligible participants must have high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer with measurable disease, an ECOG performance status of 0-1, and available tumor tissue. The study tracks tumor response, progression-free and overall survival, and detailed safety and tolerability measures, with each participant's time on treatment determined by response. The trial is sponsored by Eli Lilly in collaboration with academic cooperative groups and is being conducted at multiple cancer centers.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer who have measurable disease, ECOG 0-1, available tumor tissue, and meet the study’s platinum-resistant (Part A) or platinum-sensitive (Part B) prior-treatment criteria.

Not a fit: Patients with poor performance status (ECOG >1), non-high-grade histology, inability to provide tumor tissue, or with more prior cytotoxic therapy than allowed are unlikely to qualify or benefit from this protocol.

Why it matters

Potential benefit: If successful, Sofetabart could provide improved tumor control and potentially longer progression-free survival using a folate receptor alpha–targeted antibody-drug conjugate approach.

How similar studies have performed: Other folate receptor alpha–targeting antibody-drug conjugates such as mirvetuximab soravtansine have demonstrated clinical activity in platinum-resistant ovarian cancer, indicating the ADC approach has prior supportive evidence while Sofetabart itself is being tested in a Phase 3 setting.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Part A and B:

* Have histologically confirmed high-grade serous or high-grade 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 greater than or equal to (≥)1 but ≤3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior 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:

* 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 but ≤2 prior lines of systemic cytotoxic chemotherapy
* Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Exclusion Criteria:

Part A and B:

\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.

Part A:

\- Have primary platinum-refractory disease, defined as disease that progressed ≤3 months since the last dose of first-line platinum-containing chemotherapy.

Part B:

\- Have clinically significant proteinuria

Where this trial is running

Birmingham, Alabama and 259 other locations

+210 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm MetastasisFolate Receptor AlphaAntibody-drug ConjugatePlatinum-ResistantPlatinum-Sensitive
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.