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

Fibrolamellar Hepatocellular Carcinoma Clinical Trial

Official title:
A Phase 1b/2 Study of Glutamine Antagonist DRP-104 in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Hepatocellular Carcinoma (FLC)

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Carcinoma
Carcinoma, Hepatocellular
Fibrolamellar Hepatocellular Carcinoma

Clinical Trial Details

NCT number	NCT06027086
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact	Colleen Apostal, RN
Phone	410-614-3644
Email	GIClinicalTrials@jhmi.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	February 6, 2024
Completion date	February 1, 2027

View Details

See also
Status	Clinical Trial	Phase
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Terminated	`NCT01215565` - Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma	Phase 2
Not yet recruiting	`NCT05681949` - Therapeutic Assistance and Decision-making Algorithms in Hepatobiliary Tumor Boards	N/A
Withdrawn	`NCT02702960` - Sequential, Related Donor Partial Liver Transplantation Followed by Bone Marrow Transplantation for Hepatocellular Carcinoma (HCC)	Phase 2