A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Part B) Ovarian Cancer
NCT07213804 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1080
Last updated 2026-05-22
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.
Conditions
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Neoplasm Metastasis
Interventions
- DRUG
-
Sofetabart Mipitecan
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Topotecan
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Pegylated liposomal doxorubicin (PLD)
Administered IV
- DRUG
-
MIRV
Administered IV
- DRUG
-
Administered IV
- DRUG
-
Administered IV
Sponsors & Collaborators
-
GOG Foundation
collaborator NETWORK -
European Network of Gynaecological Oncological Trial Groups (ENGOT)
collaborator OTHER -
Asia-Pacific Gynecologic Oncology Trials Group
collaborator OTHER - lead INDUSTRY
Principal Investigators
-
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-22
- Primary Completion
- 2028-04-30
- Completion
- 2031-08-31
- FDA Drug
- Yes
Countries
- United States
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Czechia
- Denmark
- France
- Germany
- Greece
- Hungary
- Ireland
- Italy
- Japan
- Mexico
- Netherlands
- Norway
- Poland
- Romania
- South Korea
- Spain
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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