drugset
drugset / Trial / NCT06027086

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

NCT06027086 ↗

Phase 1/2 Recruiting 27 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Dracen Pharmaceuticals, Inc. · collabFibrolamellar Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether the combination of subcutaneous DRP-104 in combination with intravenous Durvalumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).

Timeline

Start
2024-02-12
Primary completion
2028-09-01
Completion
2033-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Subject sirpiglenastat Small molecule 65 mg Subcutaneous
Subject sirpiglenastat Small molecule 85 mg Subcutaneous
Subject sirpiglenastat Small molecule 105 mg Subcutaneous
Subject sirpiglenastat Small molecule 125 mg Subcutaneous
Subject sirpiglenastat Small molecule 145 mg Subcutaneous

Indications

fibrolamellar hepatocellular carcinoma