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DRP-104 (Glutamine Antagonist) in Combination With Durvalumab

Trial snapshot

  • Formal name: DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carinoma (FLC)
  • Trial type: Specifically designed for fibrolamellar carcinoma
  • Phase: Phase I
  • Recruitment status: Active, not recruiting
  • Eligible ages: 12+
  • Location: Baltimore, MD (Johns Hopkins – Sidney Kimmel Comprehensive Cancer Center)
  • ClinicalTrials.gov ID: NCT06027086

Overview

This phase I clinical trial at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University was designed to test the safety and effectiveness the experimental prodrug DRP-104 in combination with an immune checkpoint inhibitor for patients with advanced stage FLC. DRP-104 is an inactive compound that is converted into a broad-acting glutamine antagonist within tumors, while mostly remaining inactivated in other healthy tissues.

FLC tumors consume glutamine and release toxic metabolites like ammonia that create a hostile environment for immune cells that may otherwise attack the cancer. DRP-104 blocks the tumor’s glutamine metabolism, which can both slow tumor growth and make the tumor environment more supportive of an immune attack. This study was designed to test the hypothesis that blocking FLC’s glutamine metabolism can directly cause the death of FLC cancer cells and also enhance a patient’s own anti-cancer immune response. (Click here to learn more about exploiting FLC’s potential metabolic weaknesses.)

However, while still an “active” study, this effort is no longer recruiting patients. Instead, patients may want to consider enrolling in a follow-on trial — Peptide Vaccine Combined with DRP-104, Nivolumab and Ipilimumab — which is testing whether adding DRP-104 to the FLC-specific peptide vaccine therapy can improve patient response.

Trial eligibility

Enrollment in this trial was open to FLC patients 12 years old and older. For more information about this study, please visit clinicaltrials.gov (NCT06027086) or contact the clinical trials team at Johns Hopkins at GIClinicalTrials@jhmi.edu.

In the video below, Dr. Marina Baretti and Dr. Mark Yarchoan of Johns Hopkins discuss the  pre-clinical work that provided the scientific rationale for the effort, as well as the design and enrollment criteria for the study:

Trial contact information:

Please visit clinicaltrials.gov for a comprehensive list of active trials. 

The Fibrolamellar Cancer Foundation does not provide medical advice.  We provide website users with information to help them better understand their health conditions and current approaches towards diagnosis, treatment and supportive care. Always seek the advice of your physician or other qualified healthcare provider.