A Two-Part Phase 3 Study of LY4170156 in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer (FRAmework-01)

Lilly

Status and phase: Begins enrollment this month; Phase 3

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

Treatments: Drug: MIRV; Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin; Drug: Carboplatin; Drug: Bevacizumab; Drug: Topotecan; Drug: LY4170156; Drug: Gemcitabine

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 (Other Identifier)

J5E-MC-JZXB (Other Identifier)

27727

APGOT-OV17 (Other Identifier)

Details and patient eligibility

About

This is a clinical study that has two parts. It is testing a potential new medicine called LY4170156 for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A looks at participants whose cancer no longer responds to platinum-based treatments (a type of chemotherapy). Part B looks at participants whose cancer still responds to platinum-based treatments. The researchers want to find out if LY4170156 works better than the usual 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: 1,080 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Part A and B:

• Have histologically confirmed high-grade serous 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,080 participants in 4 patient groups

Part A: LY4170156

Experimental group

Description:

Administered intravenously (IV).

Treatment:

Drug: LY4170156

Part A: Chemotherapy or Mirvetuximab Soravtansine (MIRV)

Active Comparator group

Description:

Investigator's Choice of Chemotherapy or MIRV given IV.

Treatment:

Drug: Gemcitabine

Drug: Topotecan

Drug: Pegylated liposomal doxorubicin

Drug: Paclitaxel

Drug: MIRV

Part B: LY4170156 plus Bevacizumab

Experimental group

Description:

Administered IV.

Treatment:

Drug: LY4170156

Drug: Bevacizumab

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: Gemcitabine

Drug: Bevacizumab

Drug: Carboplatin

Drug: Pegylated liposomal doxorubicin

Drug: Paclitaxel