Loading clinical trials...
Loading clinical trials...
An Adaptive Clinical Platform Trial to Evaluate the Safety and Efficacy of COM701 as Monotherapy or Combination Therapy as Maintenance Therapy in Participants With Relapsed Platinum Sensitive Ovarian Cancer (PSOC)
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701. The main questions the trial aims to answer are: * Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer? * Does COM701 delay the time to needing a new anti-cancer treatment? * What side effects do participants have when taking COM701? Participants will: * Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously * Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant. * Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
Trial CPG-01-201 is an adaptive-platform trial comprised of multiple sub-studies. Sub-study 1 will be a parallel group, double-blind, randomized placebo-controlled trial in which participants will be randomized in a 1:2 ratio to either placebo (a look-alike substance that contains no drug) or COM701 treatment arms. This means that there is a 33% chance of being placed in the group getting placebo and a 67% chance of being placed in the group that will get the experimental COM701 antibody. Subsequent sub-studies will evaluate COM701 in combination with other anti-cancer drugs.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Northwestern Memorial Hospital
Warrenville, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center- Main Campus
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Hilliard, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Start Date
July 21, 2025
Primary Completion Date
March 1, 2027
Completion Date
March 1, 2027
Last Updated
February 27, 2026
60
ESTIMATED participants
COM701
DRUG
Normal Saline
DRUG
Lead Sponsor
Compugen Ltd
NCT04550494
NCT05039801
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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