CClinicalTrials.gg
RecruitingNCT06888921MAIA-ovarianUpdated Sep 29, 2026

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

A Phase 1/2 interventional study of COM701 and Normal Saline in Ovarian Cancer and Ovarian Cancer Recurrent, sponsored by Compugen Ltd. Recruiting at 28 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Compugen Ltd · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

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,
Read the 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.

02

Conditions studied

  • Ovarian Cancer
  • Ovarian Cancer Recurrent

Browse trials for

Keywords

  • maintenance therapy
  • relapsed platinum sensitive ovarian cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    COM701

    Drug: COM701

  • Placebo comparator
    Normal Saline

    Drug: Normal Saline

Interventions

  • DrugCOM701

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

  • DrugNormal Saline

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

05

What researchers measure

Primary outcomes

  1. 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

    Progression free survival in COM701-treated participants compared to placebo-treated participants

    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

Secondary outcomes

  1. To evaluate the safety and tolerability of the COM701 as a single agent when administered as a maintenance regimen in participants with relapsed PSOC

    Number of participants with adverse events in the COM701 treatment arm compared to the placebo treatment arm

    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).

  2. 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 to the initiation of a new anti-cancer treatment in COM701-treated participants compared to placebo-treated participants

    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.

06

Study locations

3 of 28 sites recruiting
  • Georgia Cancer Center at Augusta University
    Augusta, Georgia 30912, United States
    Active, not recruiting
  • The University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Active, not recruiting
  • Northwestern Memorial Hospital
    Warrenville, Illinois 60555, United States
    Active, not recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Active, not recruiting
  • Corewell Health
    Grand Rapids, Michigan 49503, United States
    Active, not recruiting
  • Memorial Sloan Kettering Cancer Center- Main Campus
    New York, New York 10065, United States
    Active, not recruiting
  • University of Rochester Medical Center
    Rochester, New York 14642, United States
    Active, not recruiting
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
    Active, not recruiting
  • Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
    Hilliard, Ohio 43026, United States
    Active, not recruiting
  • OU Health Stephenson Cancer Center
    Oklahoma City, Oklahoma 73104, United States
    Active, not recruiting
  • UPMC Magee- Womens Hospital
    Pittsburgh, Pennsylvania 15213, United States
    Active, not recruiting
  • Avera Cancer Institute
    Sioux Falls, South Dakota 57105, United States
    Active, not recruiting
  • West Cancer Center
    Germantown, Tennessee 38138, United States
    Withdrawn
  • UVA Comprehensive Cancer Center
    Charlottesville, Virginia 22903, United States
    Active, not recruiting
  • Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
    Besançon, 25000, France
    Active, not recruiting
  • Centre Oscar Lambret
    Lille, 59000, France
    Recruiting
  • Institut Paoli-Calmettes
    Marseille, 13009, France
    Active, not recruiting
  • Hospices Civils de Lyon- Centre Hospitalier Lyon Sud
    Pierre-Bénite, 69310, France
    Recruiting
  • Centre Eugene Marquis
    Rennes, 35042, France
    Active, not recruiting
  • Institut de Cancerologie de l'Ouest- Site Rene Gauducheau
    Saint-Herblain, 44805, France
    Recruiting
  • Oncopole Claudius Regaud
    Toulouse, 31059, France
    Active, not recruiting
  • Gustave Roussy
    Villejuif, 94800, France
    Active, not recruiting
  • Assuta Medical Center
    Ashdod, 7747629, Israel
    Active, not recruiting
  • Rambam Health Care Campus
    Haifa, 3109601, Israel
    Active, not recruiting
  • The Edith Wolfson Medical Center
    Holon, 5822012, Israel
    Active, not recruiting
  • Shaare Zedek Medical Center
    Jerusalem, 9103102, Israel
    Active, not recruiting
  • Hadassah, University Hospital Ein Kerem
    Jerusalem, 9112001, Israel
    Active, not recruiting
  • The Chaim Sheba Medical Center
    Ramat Gan, 5265601, Israel
    Active, not recruiting
07

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Csr

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06888921
Lead sponsor
Compugen Ltd
Responsible party
Sponsor
First posted
Mar 21, 2025
Start date
Jul 21, 2025
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Sep 29, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion