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RecruitingLast updated: 23 September 2026

FRAmework-01: Targeted treatment with Sofe-M, alone or with bevacizumab, compared with standard treatment for people with ovarian, peritoneal or fallopian tube cancer that has progressed or returned after chemotherapyA 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.

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

FRAmework-01

Clinical summary

Summary

This clinical trial is testing a targeted medicine called Sofetabart Mipitecan (Sofe-M) in people with certain types of ovarian, peritoneal, or fallopian tube cancer.

The study has three parts and includes people whose cancer has returned or continued to grow after previous treatment with platinum-based chemotherapy.

Part A (Platinum-resistant cancer)
This part is for people whose cancer became worse during treatment or within six months of finishing platinum chemotherapy. Participants will be randomly assigned (by chance) to receive either

  • Sofe-M, or
  • The study doctor will choose either standard chemotherapy or mirvetuximab soravtansine (MIRV)

Parts B and C (Platinum-sensitive cancer)
These parts will enrol people whose cancer responded to platinum chemotherapy and remained under control for at least six months after treatment ended. Participants will be randomly assigned to receive either:

  • Sofe-M plus bevacizumab
  • Platinum-based doublet chemotherapy plus bevacizumab

Researchers want to find out whether Sofe-M works better than the current standard treatments used for these cancers, and learn more about its safety and possible side effects.

Conditions

This trial is treating people with high-grade serous or high-grade endometrioid ovarian, primary peritoneal, or fallopian tube cancer

Eligibility

Inclusion

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.

Exclusion

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).

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

  • NCT07213804 *
  • 2025-522255-25-00 *
  • 27727; J5E-MC-JZXB; GOG-3133; ENGOT-OV97/GINECO-NOGGO; APGOT-OV17

Trial sponsor

Eli Lilly and Company

Scientific Title

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.

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