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A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian 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.

NCT07213804•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This is a clinical study that has two parts. It is testing a potential new medicine called Sofetabart Mipitecan (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 Sofetabart Mipitecan 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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

Locations (254)

University of Alabama at Birmingham

Birmingham, Alabama, United States

HonorHealth

Phoenix, Arizona, United States

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center

Burbank, California, United States

City of Hope, Duarte

Duarte, California, United States

Moores Cancer Center

La Jolla, California, United States

UCLA Hematology/Oncology - Westwood (Building 100)

Los Angeles, California, United States

Stanford Women's Cancer Center

Palo Alto, California, United States

Kaiser Permanente Zion Medical Center

San Diego, California, United States

Sansum Clinic

Santa Barbara, California, United States

Kaiser Permanente

Vallejo, California, United States

Key Dates

Start Date

October 22, 2025

Primary Completion Date

April 1, 2028

Completion Date

August 1, 2031

Last Updated

March 20, 2026

Enrollment

1,080

ESTIMATED participants

Conditions

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm Metastasis

Interventions

Sofetabart Mipitecan

DRUG

Paclitaxel

DRUG

Topotecan

DRUG

Gemcitabine

DRUG

Pegylated liposomal doxorubicin (PLD)

DRUG

MIRV

DRUG

Bevacizumab

DRUG

Carboplatin

DRUG

Contacts

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

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NCT06051695

Solid Tumor, AdultColorectal Cancer+18 more

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Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

Diagnosis of Multiple Cancer and Monitoring of Minimal Residual Tumors After Treatment Using Blood and High-Sensitivity Genetic Analysis Techniques

Establishment of a Tumor Bank for Tissue Samples

Institut Paoli Calmettes Ovarian Cancer Database

A Phase 1 Study of ATV-1601 in Patients With Advanced Cancer That Have AKT1 E17K Mutations