Study on the Safety and Effectiveness of COM701 in Treating Relapsed Platinum Sensitive Ovarian Cancer

Sponsor: Compugen Ltd

Sponsor score: 0

ClinicalTrials ID:NCT06888921

Provider View

This clinical trial is testing a new antibody treatment called COM701 to see if it can slow down the progression of ovarian cancer in patients whose cancer has returned after initial treatment. The study also aims to understand the safety of COM701 and its potential side effects.

Patient Parameters

Program Overview

The purpose of this study is to find out if the experimental antibody COM701 can help delay the progression of ovarian cancer in patients who have relapsed after being sensitive to platinum-based treatments. The study will also look at whether COM701 can extend the time before patients need another anti-cancer treatment and what side effects might occur. Participants will visit the clinic every three weeks to receive the treatment through an IV. They will undergo various health checks, including physical exams, vital signs, and blood tests, as well as imaging tests like CT scans or MRIs to monitor the cancer's response to the treatment.

Description

This clinical trial, known as Trial CPG-01-201, includes several smaller studies. In the first part, participants will be randomly assigned to receive either a placebo (a substance with no active drug) or the experimental antibody COM701. There is a 33% chance of receiving the placebo and a 67% chance of receiving COM701. Future parts of the study will explore how COM701 works in combination with other cancer treatments.

Eligibility Criteria

Inclusion Criteria

  • Have relapsed platinum sensitive ovarian, fallopian tube, or primary peritoneal cancer.
  • Completed at least two previous courses of platinum-based chemotherapy.
  • Achieved a partial or complete response to the last chemotherapy course, which included at least four cycles of a platinum-based regimen.
  • Previously received maintenance therapy with bevacizumab or a PARP inhibitor, or are not eligible for these treatments.
  • Recovered from side effects of previous treatments to a mild level, except for hair loss and mild nerve damage.

Exclusion Criteria

  • Have had four or more lines of chemotherapy.
  • Currently taking high doses of steroids or other immunosuppressive medications.
  • Previously treated with certain immune checkpoint inhibitors.
  • Have liver metastases or needed fluid drainage during or after the last chemotherapy.
  • Experienced bowel obstruction in the last six weeks.
  • Have active brain metastases or certain types of cancer spread to the brain or spinal cord.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Have uncontrolled infections requiring treatment.
  • Received a live vaccine within 30 days before starting the study treatment.
  • Have severe allergies to monoclonal antibodies or ingredients in the study drugs.
  • Have serious or unstable health conditions that could affect participation.
  • Participated in another clinical trial with an investigational drug or device within four weeks before starting this study.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.

Locations

FACILITYZIPCITYSTATE
West Cancer Center38138GermantownTennessee

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