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

Last updated: April 23, 2025
Sponsor: Compugen Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Vaginal Cancer

Allergies & Asthma

Ovarian Cysts

Treatment

Normal Saline

COM701

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: Normal Saline
Phase: 1/2
Study Start date:
April 01, 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

  • West Cancer Center

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

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