A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer

Last updated: March 31, 2026
Sponsor: Compugen Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Ovarian Cancer

Allergies & Asthma

Vaginal Cancer

Treatment

COM701

Normal Saline

Clinical Study ID

NCT06888921
CPG-01-201
  • Ages > 18
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

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

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

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

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

Exclusion

Exclusion Criteria:

  • Has had 4 or more lines of cytotoxic chemotherapy in total

  • Is being treated with immunosuppressive doses of systemic medications, such assteroids within 2 weeks before study drug administration

  • Has had prior treatment with PD-1, PD-L1, anti-PVRIG, TIGIT or any other check pointinhibitors

  • Presence of radiographic or biopsy proven liver metastases at the beginning orcompletion of current line of platinum-based chemotherapy.

  • Drainage of ascites during last 2 cycles of last chemotherapy or any time aftercompletion 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 withhuman immunodeficiency virus (HIV).

  • Has active and clinically relevant bacterial, fungal, or viral infection that is notcontrolled or requires systemic antibiotics, antifungals, or antivirals,respectively.

  • Has received a live viral vaccine within 30 days of planned start of study treatmentor requiring a live vaccine during the study.

  • Has a history of severe allergic, anaphylactic, or other hypersensitivity reactionsto a human or humanized monoclonal antibody (mAb) or allergy to any excipients inthe investigational products.

  • Has any serious or unstable concomitant systemic disorder

  • Has any other condition that may increase the risk associated with studyparticipation or may interfere with the interpretation of study results and, in theopinion of the investigator, would make the subject inappropriate for entry into thestudy.

  • Is currently participating in or have participated in a clinical study and receivedan investigational agent or used an investigational device within 4 weeks prior tothe first dose of study treatment.

  • Is pregnant or breastfeeding or planning to become pregnant during the period of thestudy.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: COM701
Phase: 1/2
Study Start date:
July 21, 2025
Estimated Completion Date:
March 31, 2027

Study 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.

Connect with a study center

  • Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

    Besançon, France 25000
    France

    Active - Recruiting

  • Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz

    Besançon 3033123, France 25000
    France

    Site Not Available

  • Oncopole Claudius Regaud

    Toulouse, France 31059
    France

    Active - Recruiting

  • Oncopole Claudius Regaud

    Toulouse 2972315, France 31059
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille, 59000
    France

    Active - Recruiting

  • Centre Oscar Lambret

    Lille 2998324, 59000
    France

    Site Not Available

  • Institut Paoli-Calmettes

    Marseille, 13009
    France

    Active - Recruiting

  • Institut Paoli-Calmettes

    Marseille 2995469, 13009
    France

    Site Not Available

  • Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69310
    France

    Active - Recruiting

  • Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

    Pierre-Bénite 2987314, 69310
    France

    Site Not Available

  • Centre Eugene Marquis

    Rennes, 35042
    France

    Active - Recruiting

  • Centre Eugene Marquis

    Rennes 2983990, 35042
    France

    Site Not Available

  • Institut de Cancerologie de l'Ouest- Site Rene Gauducheau

    Saint-Herblain, 44805
    France

    Active - Recruiting

  • Institut de Cancerologie de l'Ouest- Site Rene Gauducheau

    Saint-Herblain 2979590, 44805
    France

    Site Not Available

  • Gustave Roussy

    Villejuif, 94800
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif 2968705, 94800
    France

    Site Not Available

  • Assuta Medical Center

    Ashdod, 7747629
    Israel

    Active - Recruiting

  • Assuta Medical Center

    Ashdod 295629, 7747629
    Israel

    Site Not Available

  • Rambam Health Care Campus

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Rambam Health Care Campus

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • The Edith Wolfson Medical Center

    Holon, 5822012
    Israel

    Active - Recruiting

  • The Edith Wolfson Medical Center

    Holon 294751, 5822012
    Israel

    Site Not Available

  • Hadassah, University Hospital Ein Kerem

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Hadassah, University Hospital Ein Kerem

    Jerusalem 281184, 9112001
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center

    Jerusalem 281184, 9103102
    Israel

    Site Not Available

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan 293788, 5265601
    Israel

    Site Not Available

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Georgia Cancer Center at Augusta University

    Augusta 4180531, Georgia 4197000 30912
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Warrenville, Illinois 60555
    United States

    Active - Recruiting

  • The University of Chicago Medical Center

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Warrenville 4915525, Illinois 4896861 60555
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 0221502215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston 4930956, Massachusetts 6254926 0221502215
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Corewell Health

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids 4994358, Michigan 5001836 49503
    United States

    Site Not Available

  • Corewell Health

    Grand Island 5069297, Nebraska 5073708 49503
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center- Main Campus

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center- Main Campus

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester 5134086, New York 5128638 14642
    United States

    Site Not Available

  • Levine Cancer Institute

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

    Hilliard, Ohio 43026
    United States

    Active - Recruiting

  • Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

    Hilliard 5157588, Ohio 5165418 43026
    United States

    Site Not Available

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma 73104
    United States

    Active - Recruiting

  • OU Health Stephenson Cancer Center

    Oklahoma City 4544349, Oklahoma 4544379 73104
    United States

    Site Not Available

  • UPMC Magee- Womens Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • UPMC Magee- Womens Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15213
    United States

    Site Not Available

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls 5231851, South Dakota 5769223 57105
    United States

    Site Not Available

  • West Cancer Center

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • West Cancer Center

    Germantown 4624601, Tennessee 4662168 38138
    United States

    Site Not Available

  • UVA Comprehensive Cancer Center

    Charlottesville, Virginia 22903
    United States

    Active - Recruiting

  • UVA Comprehensive Cancer Center

    Charlottesville 4752031, Virginia 6254928 22903
    United States

    Site Not Available

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