COM701 for Ovarian Cancer

(MAIA-ovarian Trial)

Recruiting at 23 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Compugen Ltd

Must not be taking: Steroids, Checkpoint inhibitors

Disqualifiers: Liver metastases, CNS metastases, Hepatitis, HIV, others

Compensation: Varies

Number of Visits: 3

Duration: Up to 2 years

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental antibody called COM701 to determine if it can slow the progression of ovarian cancer after initial treatments. It examines whether COM701 can delay the need for additional cancer treatments and identifies potential side effects. Suitable candidates have relapsed ovarian, fallopian tube, or primary peritoneal cancer, have undergone at least two rounds of platinum-based treatments, and have experienced some success with their last chemotherapy. Participants will visit the clinic every three weeks for treatment and tests to monitor their health and cancer status. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on immunosuppressive doses of systemic medications like steroids within 2 weeks before starting the study treatment.

Is there any evidence suggesting that COM701 is likely to be safe for humans?

Research has shown that COM701 has been tested in several studies with patients who have platinum-resistant ovarian cancer. In these studies, COM701 was generally well-tolerated, meaning most people did not experience serious problems. Some side effects were reported, but they were manageable. Safety data from past patients indicate that COM701, whether used alone or with other treatments, did not cause severe side effects for most participants. This suggests the treatment is relatively safe. However, like any treatment, side effects can occur and may vary from person to person. Participants should discuss potential risks and benefits with their healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ovarian cancer?

Researchers are excited about COM701 for ovarian cancer because it represents a novel approach to treatment. Unlike standard therapies like chemotherapy and targeted drugs, which often focus on directly killing cancer cells or inhibiting specific growth signals, COM701 is an immunotherapy. It works by targeting a protein called PVRIG, which is involved in suppressing the immune system's response to cancer. By blocking this protein, COM701 aims to unleash the body’s natural defenses to better fight the cancer, potentially offering a new option for patients who don’t respond well to existing treatments.

What evidence suggests that COM701 might be an effective treatment for ovarian cancer?

Research has shown that COM701, which participants in this trial may receive, may help treat ovarian cancer, particularly in patients who have undergone several prior treatments. Studies found that COM701 was generally safe and led to lasting improvements in these patients. In early results, 20% of patients experienced tumor shrinkage, and 25% maintained stable disease, meaning their cancer did not progress. While these findings are promising, more information is needed to fully understand the treatment's effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with relapsed platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. They must have completed at least two prior platinum-based therapies and recovered from previous treatment side effects (except mild neuropathy and hair loss). Participants should have responded to their last chemotherapy and may not be candidates for or have declined certain other maintenance therapies.

Inclusion Criteria

I have recovered from previous cancer treatment side effects, except for hair loss and mild nerve pain.

My last chemo had at least 4 cycles with platinum and my cancer partially or completely shrank.

I have completed 2 rounds of platinum-based cancer treatment.

Exclusion Criteria

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 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive COM701 or placebo intravenously every 3 weeks as maintenance therapy

Up to 2 years

Visit the clinic once every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days post last cycle

What Are the Treatments Tested in This Trial?

Interventions

• COM701

Trial Overview

The study tests the experimental antibody COM701 as a maintenance treatment to see if it can delay ovarian cancer progression. Patients will receive COM701 intravenously every three weeks and undergo regular health monitoring through physical exams, vital signs checks, ECGs, blood/urine tests, imaging scans like CT/MRI, and tumor tissue analysis.

How Is the Trial Designed?

Group I: COM701 Experimental Treatment 1 Intervention

Group II: Normal Saline Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Compugen Ltd

Lead Sponsor

Trials

5

Recruited

540+

Published Research Related to This Trial

Optimal surgical debulking to achieve no residual disease (R0) significantly improves survival rates in patients with epithelial ovarian cancer, which is crucial given its high mortality rate.

The SOLO-1 trial demonstrated that olaparib, a maintenance therapy, significantly reduces the risk of disease progression by 70% in patients with advanced ovarian cancer who have BRCA mutations, highlighting its efficacy in targeted treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Treatment of Primary Advanced Ovarian Cancer. Friedrich, M., Friedrich, D., Kraft, C., et al.[2021]

In a study of 779 Jewish women with ovarian cancer, those with BRCA1/2 mutations had a significantly longer median survival (53.7 months) compared to non-carriers (37.9 months), indicating a 28% reduction in mortality for mutation carriers.

The survival advantage for BRCA1/2 carriers was particularly notable in advanced stages (III to IV) and among women with poor-grade tumors, suggesting that these mutations may influence the clinical behavior of the cancer or improve responses to chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of BRCA1/2 mutations on long-term survival of patients with invasive ovarian cancer: the national Israeli study of ovarian cancer. Chetrit, A., Hirsh-Yechezkel, G., Ben-David, Y., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06888921

Study Details | NCT06888921 | A Clinical Trial to Evaluate ...

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 ...

2.

ir.cgen.com

ir.cgen.com/news-and-events/news/news-details/2025/Compugen-Reports-Third-Quarter-2025-Results/default.aspx

Compugen Reports Third Quarter 2025 Results

COM701 Phase 1 data presented at ESMO 2025 characterized patients who derived clinical benefit and informed the design of the ongoing ...

3.

prnewswire.com

prnewswire.com/il/news-releases/compugen-to-present-pooled-analysis-of-com701-in-three-phase-1-trials-in-patients-with-platinum-resistant-ovarian-cancer-at-esmo-2025-302581918.html

Compugen to Present Pooled Analysis of COM701 in ...

"The pooled analysis demonstrates that COM701 was well tolerated and showed consistent, durable responses in patients with heavily pretreated ...

4.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/585756

A Clinical Trial to Evaluate the Safety and Efficacy of ...

The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants ...

5.

onclive.com

onclive.com/view/com701-plus-bms-986207-nivolumab-shows-early-activity-in-platinum-resistant-ovarian-cancer

COM701 Plus BMS-986207/Nivolumab Shows Early ...

Of those who responded to treatment, 20% had a partial response, 25% achieved stable disease, and 55% experienced disease progression. The ...

6.

ir.cgen.com

ir.cgen.com/news-and-events/news/news-details/2024/Compugen-to-Present-Anti-Tumor-Activity-and-Safety-Data-of-COM701-COM902-and-Pembrolizumab-Combination-in-Patients-with-Platinum-Resistant-Ovarian-Cancer-at-SITC-2024/default.aspx

News Details

COM701 in combination with COM902 (Fc reduced anti-TIGIT) and pembrolizumab (anti-PD-1) resulted in durable objective responses in late-stage ...

7.

cgen.com

cgen.com/pipeline/com701-pvrig/

COM701/Fc reduced Anti-PVRIG antibody

An adaptive platform trial to evaluate the safety and efficacy of COM701 as maintenance monotherapy or combination therapy in patients with relapsed platinum ...

8.

trialstoday.org

trialstoday.org/trial/NCT06888921

A Clinical Trial to Evaluate the Safety and Efficacy of ...

Purpose. The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in ...