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 (FRAmework-01)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Neoplasm Metastasis

Treatments: Drug: MIRV; Drug: Carboplatin; Drug: Sofetabart Mipitecan; Drug: Gemcitabine; Drug: Topotecan; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Bevacizumab

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT07213804

2025-522255-25-00 (EU Trial (CTIS) Number)

GOG-3133 (Other Identifier)

ENGOT-ov97/GINECO-NOGGO-AGO-A (Other Identifier)

J5E-MC-JZXB (Other Identifier)

27727

APGOT-OV17 (Other Identifier)

Details and patient eligibility

About

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 standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.

Enrollment: 1,630 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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 criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,630 participants in 6 patient groups

Part A: Sofetabart Mipitecan

Experimental group

Description:

Administered intravenously (IV).

Treatment:

Drug: Sofetabart Mipitecan

Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)

Active Comparator group

Description:

Investigator's Choice of Chemotherapy or MIRV given IV.

Treatment:

Drug: Pegylated liposomal doxorubicin (PLD)

Drug: Paclitaxel

Drug: Topotecan

Drug: Gemcitabine

Drug: MIRV

Part B: Sofetabart Mipitecan plus Bevacizumab

Experimental group

Description:

Administered IV.

Treatment:

Drug: Bevacizumab

Drug: Sofetabart Mipitecan

Part B: Platinum-based Doublet Chemotherapy plus Bevacizumab

Active Comparator group

Description:

Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.

Treatment:

Drug: Bevacizumab

Drug: Pegylated liposomal doxorubicin (PLD)

Drug: Paclitaxel

Drug: Gemcitabine

Drug: Carboplatin

Part C: Sofetabart Mipitecan plus Bevacizumab

Experimental group

Description:

Administered IV

Treatment:

Drug: Bevacizumab

Drug: Sofetabart Mipitecan

Part C: Platinum-based Doublet Chemotherapy plus Bevacizumab

Active Comparator group

Description:

Investigator's choice of platinum doublet chemotherapy IV followed by bevacizumab IV.

Treatment:

Drug: Bevacizumab

Drug: Pegylated liposomal doxorubicin (PLD)

Drug: Paclitaxel

Drug: Gemcitabine

Drug: Carboplatin