OncoMatch/Clinical Trials/NCT06027086
DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Is NCT06027086 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Durvalumab and DRP-104 for fibrolamellar hepatocellular carcinoma.
Treatment: Durvalumab · DRP-104 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: DNAJB1 DNAJB1-PRKACA fusion transcript
Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunotherapy
Must have demonstrated radiographic progression on prior or current immunotherapy.
Cannot have received: chemotherapy
Exception: chemotherapy, biological cancer therapy, or radiation 21 days prior to the first dose of study drug
Patients who have had chemotherapy, biological cancer therapy, or radiation 21 days prior to the first dose of study drug.
Cannot have received: surgery
Exception: surgery within 28 days of dosing of investigational agent, excluding minor procedures
Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures.
Cannot have received: other approved or investigational agents or device
Exception: within 21 days of the first dose of study drug
Patients who have received other approved or investigational agents or device within 21 days of the first dose of study drug.
Lab requirements
Blood counts
adequate organ and marrow function defined by study-specified laboratory tests
Kidney function
adequate kidney function defined by study-specified laboratory tests
Liver function
adequate liver function defined by study-specified laboratory tests
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Johns Hopkins SKCCC · Baltimore, Maryland
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