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)

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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,

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

• Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy

• For the last chemotherapy course prior to being randomized into the study, must have had a minimum of 4 cycles of a platinum containing regimen and achieved a partial or complete tumor response.

• Has received prior maintenance therapy with bevacizumab or a PARP inhibitor if eligible and is not a candidate for, or has declined in writing, bevacizumab or PARP inhibitor therapy.

• Have recovered from toxicities of prior chemotherapy or other therapy (to grade 1 or less, except for alopecia and neuropathy recovered to a ≤grade 2).

Locations
United States
Illinois
The University of Chicago Medical Center
RECRUITING
Chicago
Northwestern Memorial Hospital
RECRUITING
Warrenville
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Corewell Health
RECRUITING
Grand Rapids
New York
Memorial Sloan Kettering Cancer Center- Main Campus
RECRUITING
New York
Ohio
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
RECRUITING
Hilliard
South Dakota
Avera Cancer Institute
RECRUITING
Sioux Falls
Tennessee
West Cancer Center
RECRUITING
Germantown
Virginia
UVA Comprehensive Cancer Center
RECRUITING
Charlottesville
Other Locations
France
Centre Oscar Lambret
RECRUITING
Lille
Institut Paoli-Calmettes
RECRUITING
Marseille
Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
RECRUITING
Pierre-bénite
Centre Eugene Marquis
RECRUITING
Rennes
Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
RECRUITING
Saint-herblain
Oncopole Claudius Regaud
RECRUITING
Toulouse
Gustave Roussy
RECRUITING
Villejuif
Israel
Assuta Medical Center
RECRUITING
Ashdod
Rambam Health Care Campus
RECRUITING
Haifa
The Edith Wolfson Medical Center
RECRUITING
Holon
Hadassah, University Hospital Ein Kerem
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Time Frame
Start Date: 2025-07-21
Estimated Completion Date: 2027-03
Participants
Target number of participants: 60
Treatments
Experimental: COM701
Placebo_comparator: Normal Saline
Related Therapeutic Areas
Sponsors
Leads: Compugen Ltd

This content was sourced from clinicaltrials.gov