COM701 for Ovarian Cancer

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

Trial Summary

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.

How does the drug COM701 differ from other treatments for ovarian cancer?

COM701 is a novel treatment for ovarian cancer that may work differently from standard options like chemotherapy and PARP inhibitors. While standard treatments often target cancer cells directly or exploit genetic mutations like BRCA1/2, COM701 could involve a unique mechanism, possibly related to immune modulation, which is not a common approach in current ovarian cancer therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Multimodal Treatment of Primary Advanced Ovarian Cancer. [2021]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An Open-label, Multicenter, Single-arm, Phase II Study of Fluzoparib in Patients with Germline BRCA1/2 Mutation and Platinum-sensitive Recurrent Ovarian Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Recent Discovery of PARP7 Inhibitors as Anticancer Agents. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Morphological and molecular heterogeneity of epithelial ovarian cancer: Therapeutic implications. [2020]