Actively Recruiting

Phase 1
Phase 2
Age: 12Years +
All Genders
NCT06027086

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

Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2026-02-12

27

Participants Needed

1

Research Sites

498 weeks

Total Duration

On this page

Sponsors

S

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

D

Dracen Pharmaceuticals, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed fibrolamellar carcinoma that is metastatic or unresectable.
  • Presence of DNAJB1-PRKACA fusion transcript detected by RNA-sequencing, DNA-sequencing, or in situ hybridization.
  • Radiographic disease progression on prior or current immunotherapy.
  • Age 12 years or older.
  • Patients under 18 years must weigh at least 40 kg.
  • ECOG performance status of 0, 1, or 2.
  • Adequate organ and marrow function based on study laboratory tests.
  • Adequate kidney and liver function per study laboratory tests.
  • Measurable disease according to RECIST 1.1 criteria.
  • Willingness to provide tissue and blood samples for mandatory translational research.
  • Women of childbearing potential must have a negative pregnancy test.
  • Both women and men must agree to use acceptable birth control during the study.
  • Ability to understand and sign informed consent.
Not Eligible

You will not qualify if you...

  • Chemotherapy, biological cancer therapy, or radiation within 21 days before first study drug dose.
  • Surgery within 28 days before dosing, except minor procedures.
  • Receipt of other approved or investigational agents or devices within 21 days before first study drug dose.
  • Not recovered from prior acute adverse events to grade 1 or baseline, except certain manageable conditions.
  • Corrected QT interval over 470 ms.
  • Use of strong CYP 3A4/5 inducers that cannot be stopped at least 14 days before treatment.
  • Known allergy or sensitivity to DRP-104 or durvalumab or similar compounds.
  • Symptomatic interstitial lung disease or conditions interfering with pulmonary toxicity management.
  • Oxygen saturation below 92% on room air or need for home oxygen.
  • Active or untreated brain or leptomeningeal metastases.
  • Uncontrolled active medical or psychiatric illness that limits study compliance.
  • Pregnant or breastfeeding.
  • Known HIV/AIDS infection.
  • Active hepatitis B infection.
  • Active or acute diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
  • Unwillingness or inability to follow study schedule.
  • Current or recent (within one year) illicit drug use or substance abuse.
  • Clinical evidence of ascites.
  • History of severe toxicities from PD-1 or PD-L1 therapies.
  • Active autoimmune disease requiring systemic treatment in past 2 years.
  • Prior allogeneic stem cell or organ transplantation.
  • Diagnosis of immunodeficiency.
  • Use of systemic corticosteroids at immunosuppressive doses.
  • Receipt of live attenuated vaccine within 4 weeks before treatment.
  • Allergen hyposensitization therapy within 2 weeks before treatment.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Johns Hopkins SKCCC

Baltimore, Maryland, United States, 21231

Actively Recruiting

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Research Team

C

Colleen Apostal, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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