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
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:
Participants will:
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.
Exclusion Criteria:
Drug: COM701
Drug: Normal Saline
COM701 will be administered via intravenous (IV) infusion once every 3 weeks.
Saline will be administered via intravenous (IV) infusion once every 3 weeks
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
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).
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.
Plan to share: Yes
Supporting information: Study protocol, Csr
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Compugen Ltd