DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

February 12, 2024

Primary Completion Date

September 1, 2028

Study Completion Date

September 1, 2033

Conditions
Fibrolamellar Hepatocellular Carcinoma
Interventions
DRUG

Durvalumab

Patients will receive treatment on Day 1 of each cycle. Durvalumab (1500 mg) will be administered IV on Day 1 of each cycle every 28 days.

DRUG

DRP-104

"Patients will receive treatment twice a week of each cycle. DRP-104 (145 mg,125mg, 105mg, 85mg or 65mg) will be administered subcutaneous injection twice a week of each 28 day cycle.~After the first cycle of treatment the study drug may be shipped to the patient's home for future cycles of administration if patients or caregiver can demonstrate at least two observed independent injections of DRP-104 prior to home administration."

Trial Locations (1)

21231

RECRUITING

Johns Hopkins SKCCC, Baltimore

Sponsors
All Listed Sponsors
collaborator

Dracen Pharmaceuticals, Inc.

INDUSTRY

collaborator

Fibrolamellar Cancer Foundation

OTHER

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER