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

Summary

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.

Conditions

• Ovarian Neoplasms
• Fallopian Tube Neoplasms
• Peritoneal Neoplasms
• Neoplasm Metastasis

Interventions

DRUG

Sofetabart Mipitecan

Administered IV

DRUG

Paclitaxel

Administered IV

DRUG

Topotecan

Administered IV

DRUG

Gemcitabine

Administered IV

DRUG

Pegylated liposomal doxorubicin (PLD)

Administered IV

DRUG

MIRV

Administered IV

DRUG

Bevacizumab

Administered IV

DRUG

Carboplatin

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

• Eli Lilly and Company

  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

2028-11-30

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
• Singapore
• South Korea
• Spain
• Switzerland
• Taiwan
• United Kingdom

Study Locations