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NCT06888921From ClinicalTrials.govRecruiting

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

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)

  • Ovarian Cancer
  • Ovarian Cancer Recurrent

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Compugen Ltd
Enrolment target
60
Started
21 July 2025
Main results due
March 2027
Study sites
28
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Women only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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 sites(28)

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, United States

    Active, not recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois, United States

    Active, not recruiting

  • Northwestern Memorial Hospital

    Warrenville, Illinois, United States

    Active, not recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, United States

    Active, not recruiting

  • Corewell Health

    Grand Rapids, Michigan, United States

    Active, not recruiting

  • Memorial Sloan Kettering Cancer Center- Main Campus

    New York, New York, United States

    Active, not recruiting

  • University of Rochester Medical Center

    Rochester, New York, United States

    Active, not recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, United States

    Active, not recruiting

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

    Hilliard, Ohio, United States

    Active, not recruiting

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, United States

    Active, not recruiting

  • UPMC Magee- Womens Hospital

    Pittsburgh, Pennsylvania, United States

    Active, not recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota, United States

    Active, not recruiting

  • West Cancer Center

    Germantown, Tennessee, United States

    Withdrawn

  • UVA Comprehensive Cancer Center

    Charlottesville, Virginia, United States

    Active, not recruiting

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

    Besançon, France

    Active, not recruiting

  • Centre Oscar Lambret

    Lille, France

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, France

    Active, not recruiting

  • Hospices Civils de Lyon- Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

    Recruiting

  • Centre Eugene Marquis

    Rennes, France

    Active, not recruiting

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

    Saint-Herblain, France

    Recruiting

  • Oncopole Claudius Regaud

    Toulouse, France

    Active, not recruiting

  • Gustave Roussy

    Villejuif, France

    Active, not recruiting

  • Assuta Medical Center

    Ashdod, Israel

    Active, not recruiting

  • Rambam Health Care Campus

    Haifa, Israel

    Active, not recruiting

  • The Edith Wolfson Medical Center

    Holon, Israel

    Active, not recruiting

  • Shaare Zedek Medical Center

    Jerusalem, Israel

    Active, not recruiting

  • Hadassah, University Hospital Ein Kerem

    Jerusalem, Israel

    Active, not recruiting

  • The Chaim Sheba Medical Center

    Ramat Gan, Israel

    Active, not recruiting

Showing 28 of 28 sites. 3 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06888921. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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