Recruiting

Phase 1

Phase 2

COM701A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer

Sponsor:

Compugen Ltd

Code:

NCT06888921

Conditions

Ovarian Cancer

Ovarian Cancer Recurrent

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COM701

Normal Saline

Study Details

Brief 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,

Conditions

Ovarian Cancer

Ovarian Cancer Recurrent

Study ID

NCT06888921

Start date

Jul 21, 2025

Status verified date

Sep, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: COM701

placebo comparator: Normal Saline

Interventions

COM701

COM701 will be administered via intravenous (IV) infusion once every 3 weeks.

Normal Saline

Saline will be administered via intravenous (IV) infusion once every 3 weeks

Primary outcome measure

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 ]

Central Contacts and Locations

Locations

Georgia Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Study Coordinator

(706) 721-8978 dwheatley@augusta.edu

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Research Manager

773-702-6216 vseseri@bsd.uchicago.edu

Northwestern Memorial Hospital

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Study Coordinator

630-352-5360 donald.smith3@nm.org

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Study Coordinator

617-726-5085 mblessing1@mgh.harvard.edu

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Study Coordinator

616-486-1545 rachel.schmidt@corewellhealth.org

Memorial Sloan Kettering Cancer Center- Main Campus

Recruiting

New York, New York, United States, 10065

Contacts

Study Coordinator

(347) 798-9213 nortmant@mskcc.org

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14642

Contacts

Study Coordinator

(585) 442-8020 jamie_krest@urmc.rochester.edu

Levine Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Study Coordinator

980-442-2333 leah.j.wilson@atriumhealth.org

Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run

Recruiting

Hilliard, Ohio, United States, 43026

Contacts

Study Coordinator

(614) 814-9717 joanna.marshall@sumc.edu

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Study Coordinator

405-271-8707 nikolas-williams@ou.edu

UPMC Magee- Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Study Coordinator

412-641-3575 shellenbargerjr@upmc.edu

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Study Coordinator

(605) 322-3000 natasha.flier@avera.org

UVA Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Study Coordinator

(434) 924-9333 hxc9qv@uvahealth.org

More Information

Sponsor

Compugen Ltd

Last update posted

Apr 1, 2026

Last verified

Sep, 2025

Keywords

maintenance therapy
relapsed platinum sensitive ovarian cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Compugen Ltd on 2026-04-01.