Study on VVD-133214 and Pembrolizumab for Advanced Colon or Rectal Cancer

Sponsor: Vividion Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT07811193

This clinical trial is testing a new treatment combination of VVD-133214 and pembrolizumab to see if it works better than pembrolizumab alone for people with advanced colorectal cancer that has specific genetic features.

Patient Parameters

Program Overview

Researchers are exploring a new treatment for advanced colorectal cancer, which affects the colon or rectum. This study focuses on cancers that cannot be removed by surgery or have spread to other parts of the body. Some cancer cells have a faulty repair system called dMMR, leading to a condition known as MSI. These cells rely on a protein called Werner helicase to survive. The study drug, VVD-133214, aims to block this protein, potentially stopping cancer cells from growing. The study will test VVD-133214 with pembrolizumab, an approved immunotherapy, to see if this combination is more effective than pembrolizumab alone. Participants will receive regular check-ups to monitor their health and the cancer's response to treatment.

Eligibility Criteria

Inclusion Criteria

  • Must be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have advanced colorectal cancer with specific genetic features (MSI and/or dMMR) confirmed by standard tests.
  • Have not received prior treatment for advanced cancer that has spread.
  • Must provide a tumor sample for testing.
  • Have measurable cancer according to standard criteria.
  • Have good blood and organ function based on recent lab tests.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

  • Have received prior treatment for advanced colorectal cancer, except for certain chemotherapy if the cancer returned after 12 months.
  • Have had previous immunotherapy treatments.
  • Have active or uncontrolled cancer spread to the brain or central nervous system.
  • Have a history of autoimmune disease or immune deficiency needing treatment in the past 2 years.
  • Have had another cancer within the last 5 years, except for Lynch syndrome.
  • Need treatment with immunosuppressive medications.
  • Have active hepatitis B, hepatitis C, or HIV.
  • Have Werner Syndrome.
  • Have had previous treatment with a Werner helicase inhibitor.

Locations

FACILITYZIPCITYSTATE
University of Arizona Cancer Center - North Campus85719TucsonArizona
University of Michigan Rogel Cancer Center48109Ann ArborMichigan
Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit48202DetroitMichigan
Mary Babb Randolph Cancer Center26505MorgantownWest Virginia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.