A Phase 1/2 Study of GRT-C903/GRT-R904, a Vaccine Targeting Shared Neoantigens, in Combination with Immune Checkpoint Blockade for Patients with Advanced Solid Tumors

Contact:

NCT Number:

Protocol:

AAAS5371

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

The purpose of this study is to learn more about the safety of a cancer vaccine that teaches the immune system to recognize and possibly destroy tumor cells, and to assess how well the vaccine works. The vaccine has two components. One of them is study drug GRT-C903, and the other is GRT-C904. The vaccine works by stimulating the immune system, which then fights tumors by recognizing and destroying tumor cells. This vaccine will be used in combination with FDA approved drugs ipilimumab and nivolumab, which are medications that activate the immune system. The overall study treatment, which consists of the vaccine plus the ipilimumab and nivolumab, is not yet approved by the FDA, and is being tested in this study to see if it is safe and if it can help your body control your cancer.

Are you Eligible? (Inclusion Criteria)

  • Are you an adult 18 years old or older?
  • Do you have advanced or metastatic: A. Microsatellite Stable Colorectal Cancer? - If so, are you currently receiving treatment with fluoropyrimidine and oxaliplatin and/or irinotecan OR have you received this treatment and experienced disease progression, but not started a new therapy yet? B. Non small-cell lung cancer? - If so, are you currently receiving treatment with an anti-PL-(L)1 antibody in combination with cytotoxic, platinum-based chemotherapy OR have you received this treatment and experienced disease progression, but not started a new therapy yet? C. Pancreatic Ductal Adenocarcinoma? - If so, are you currently receiving cytotoxic chemotherapy OR have you received this treatment and experienced disease progression, but not started a new therapy yet? D. Any kind of solid tumor histology where you have experienced disease progression with all available therapies known to offer benefit?
  • Are you willing to undergo research biopsies?

Specialty Area(s)

Colon and Rectal Cancer, Liver Cancer, Pancreatic Cancer, Stomach Cancer, Immunotherapy

Principal Investigator

Profile Headshot
  • Associate Director, Experimental Therapeutics
  • Director of Translational Research, Upper Aerodigestive Cancers in Medical Oncology

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032