In the attached video, Mark Yarchoan, MD and Marina Baretti, MD of Johns Hopkins University discuss the launch of a new clinical trial specifically for fibrolamellar patients that leverages the recently-identified “glutamine addiction” of FLC tumors.

The trial, named “DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma” is now open for patient enrollment at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland. The study plans to test the safety and effectiveness the experimental prodrug DRP-104 in combination with an immune checkpoint inhibitor. 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. 

In the video, the team discusses the pre-clinical work that provided the scientific rationale for the effort, as well as the design and enrollment criteria for the trial. According to Mark Yarchoan, “One of the things I am really proud of is how quickly this trial has moved from inception to opening. … It wouldn’t be possible without the enormous support of multiple different funding sources.”

The Fibrolamellar Cancer Foundation has provided the funding to support the launch of this trial and its protocol design, and helped secure drug access for the trial through a partnership with Dracen Pharmaceuticals, the developer of DRP-104. Additional funding for the trial is also being provided by the Cancer Research Institute and the National Cancer Institute, the principal agency for cancer research and training of the U.S. government’s National Institutes of Health.

For more information about this new study, please visit clinicaltrials.gov (NCT06027086) or contact the clinical trials team at Johns Hopkins at GIClinicalTrials@jhmi.edu.