A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer (MAIA-ovarian)

March 31, 2026 updated by: Compugen Ltd

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,

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59000
        • Recruiting
        • Centre Oscar Lambret
        • Contact:
      • Marseille, France, 13009
        • Recruiting
        • Institut Paoli-Calmettes
        • Contact:
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
        • Contact:
      • Rennes, France, 35042
      • Saint-Herblain, France, 44805
        • Recruiting
        • Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
        • Contact:
      • Villejuif, France, 94800
    • France
      • Besançon, France, France, 25000
        • Recruiting
        • Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz
        • Contact:
      • Toulouse, France, France, 31059
  • Israel
      • Ashdod, Israel, 7747629
        • Recruiting
        • Assuta Medical Center
        • Contact:
      • Haifa, Israel, 3109601
      • Holon, Israel, 5822012
        • Recruiting
        • The Edith Wolfson Medical Center
        • Contact:
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
        • Contact:
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah, University Hospital Ein Kerem
        • Contact:
      • Ramat Gan, Israel, 5265601
  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Georgia Cancer Center at Augusta University
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • The University of Chicago Medical Center
        • Contact:
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center- Main Campus
        • Contact:
      • Rochester, New York, United States, 14642
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • Ohio
      • Hilliard, Ohio, United States, 43026
        • Recruiting
        • Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Magee- Womens Hospital
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Withdrawn
        • West Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Recruiting
        • UVA Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Has had 4 or more lines of cytotoxic chemotherapy in total
  • Is being treated with immunosuppressive doses of systemic medications, such as steroids within 2 weeks before study drug administration
  • Has had prior treatment with PD-1, PD-L1, anti-PVRIG, TIGIT or any other check point inhibitors
  • Presence of radiographic or biopsy proven liver metastases at the beginning or completion of current line of platinum-based chemotherapy.
  • Drainage of ascites during last 2 cycles of last chemotherapy or any time after completion of the last chemotherapy regimen.
  • Bowel obstruction in the 6 weeks prior to randomization.
  • Have known active central nervous system metastases and/or carcinomatous meningitis / leptomeningeal carcinomatosis.
  • Has active hepatitis B virus (HBV) or hepatitis C virus (HCV), or subjects with human immunodeficiency virus (HIV).
  • Has active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires systemic antibiotics, antifungals, or antivirals, respectively.
  • Has received a live viral vaccine within 30 days of planned start of study treatment or requiring a live vaccine during the study.
  • Has a history of severe allergic, anaphylactic, or other hypersensitivity reactions to a human or humanized monoclonal antibody (mAb) or allergy to any excipients in the investigational products.
  • Has any serious or unstable concomitant systemic disorder
  • Has any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the opinion of the investigator, would make the subject inappropriate for entry into the study.
  • Is currently participating in or have participated in a clinical study and received an investigational agent or used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Is pregnant or breastfeeding or planning to become pregnant during the period of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal Saline
Drug: Normal Saline
Saline will be administered via intravenous (IV) infusion once every 3 weeks
Experimental: COM701
Drug: COM701
COM701 will be administered via intravenous (IV) infusion once every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the effect of COM701 as a single agent on progression free survival when administered as a maintenance regimen in participants with relapsed PSOC
Time Frame: From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years
Progression free survival in COM701-treated participants compared to placebo-treated participants
From the date of randomization until the date of disease progression, or date of death from any cause whichever occurs first, assessed up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC
Time Frame: From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).
Number of participants with adverse events in the COM701 treatment arm compared to the placebo treatment arm
From randomization up to 90 days post last cycle of study treatment (each cycle is 3 weeks; study treatment may continue up to 2 years).
To evaluate the effect of COM701 as a single agent on other efficacy endpoints when administered as a maintenance regimen in participants with relapsed PSOC
Time Frame: From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.
Time to the initiation of a new anti-cancer treatment in COM701-treated participants compared to placebo-treated participants
From date of randomization until the date of the initiation of a new anti-cancer treatment, or date of death from any cause whichever occurs first, assessed up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Compugen Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 21, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPG-01-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

Within 12 months of final database lock

IPD Sharing Access Criteria

To be decided

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Cancer

Clinical Trials on COM701

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe