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

{ "DRP-104 with Durvalumab for Advanced Fibrolamellar Carcinoma", "This study is testing a combination of two drugs, DRP-104 and Durvalumab, for patients with advanced fibrolamellar carcinoma (FLC), a rare liver cancer. DRP-104 is given as a shot under the skin twice a week, and Durvalumab is given through an IV once every 28 days. After the first cycle, DRP-104 may be sent to your home. To join, you must have FLC that has spread or cannot be removed by surgery, and your cancer must have a specific genetic change called DNAJB1-PRKACA. You also need to have shown your cancer is growing despite previous or current immunotherapy. The study aims to see if this combination is safe and if it can shrink tumors. There are 27 participants planned for this study.", "design": "This is an interventional study with 27 planned participants. The study is testing a combination of two drugs, DRP-104 and Durvalumab.", "commitments": "You would receive Durvalumab intravenously every 28 days and DRP-104 as a subcutaneous injection twice a week. After the first cycle, DRP-104 may be shipped to your home for future cycles.", "compensation": "Not stated in the trial record.", "follow_up": "The study will measure adverse events and tumor response for up to 4 years.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE1Ages 12+InterventionalTreatment

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

~27 participants

Updated 2026-02-12 on ClinicalTrials.gov

What's tested:DurvalumabDRP-104

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of participants experiencing drug-related adverse events (AEs) requiring treatment discontinuation

Measured over 4 years

+1 more outcome measured

Conditions

Fibrolamellar Hepatocellular Carcinoma

NCT06027086

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Johns Hopkins SKCCC
Baltimore, Marylandstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Marina Baretti, MD · PRINCIPAL_INVESTIGATOR · SKCCC • Johns Hopkins Medical Institution

Who to contact

Colleen Apostal, RN

[email protected]

410-614-3644

Email the study team

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Eligibility criteria

Inclusion

Must have histologically confirmed FLC (Fibrolamellar Carcinoma) that is metastatic or unresectable.

Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.

Must have demonstrated radiographic progression on prior or current immunotherapy.

Age ≥ 12 years.

Patients \< 18 years old must have a body weight ≥ 40 kg.

Eastern Cooperative Oncology Group (ECOG) performance status of ≤2

Patients must have adequate organ and marrow function defined by study-specified laboratory tests.

Patients must have adequate kidney and liver function defined by study-specified laboratory tests.

Must have measurable disease per RECIST 1.1

Willingness to provide tissue and blood samples for mandatory translational research.

Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.

For both Women and Men, must use acceptable form of birth control while on study.

Ability to understand and willingness to sign a written informed consent document.

Exclusion

Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:

Patients who have had chemotherapy, biological cancer therapy, or radiation 21 days prior to the first dose of study drug.

Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures.

Patients who have received other approved or investigational agents or device within 21 days of the first dose of study drug.

Patients who have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of grade 2 fatigue, rash, and endocrinopathy successfully managed hormone replacement therapy, or alopecia or stable neuropathy, unless approved by the investigational new drug (IND) Sponsor.

Patients with corrected QT interval (QTc) prolongation \> 470 ms according to Fridericia formula.

Patients receiving potent inducers of Cytochrome P450 3A (CYP 3A4/5) (including apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin and St. John's Wort) that cannot be discontinued at least 14 days prior to Cycle 1 Day 1.

Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition of DRP-104 or durvalumab.

Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.

Has a pulse oximetry of \<92% on room air or is on supplemental home oxygen.

Active or untreated brain metastases or leptomeningeal metastases.

Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.

Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant or breastfeeding.

Has a known history of Human Immunodeficiency Virus (HIV)/AIDS.

Has active hepatitis B. Patients with chronic or acute hepatitis B virus (HBV) infection .

Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study.

Patient is unwilling or unable to follow the study schedule for any reason.

Patient is at the time of signing informed consent a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).

Evidence of clinical ascites.

Participants a with history of prior unacceptable and/or life-threatening toxicities attributed to anti-programmed death-receptor 1 (PD1) or anti-PD-L1 (anti-programmed death-receptor 1) therapy.

Has active autoimmune disease that has required systemic treatment in the past 2 years.

Prior allogeneic stem cell transplantation or organ transplantation.

Has a diagnosis of immunodeficiency.

Systemic corticosteroids at immunosuppressive doses.

Patients who have had either of the following procedures or medications within 4 weeks prior to initiation of study treatment:

Any live, attenuated vaccine

Allergen hypo sensitization therapy in the last 2 weeks

What this trial measures

Number of participants experiencing drug-related adverse events (AEs) requiring treatment discontinuation4 years
When calculating the incidence of AEs, each AE (as defined by NCI Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) will be counted only once for a given subject.
Objective response rate (ORR) using immune Response Evaluation Criteria for Solid Tumors (RECIST 1.1)4 years
ORR is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) to DRP-104 (glutamine antagonist) in combination with duvalumab, based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, PR is =\>30percent decrease in sum of diameters of target lesions, progressive disease (PD) is \>20percent increase in sum of diameters of target lesions, stable disease (SD) is \<30percent decrease or \<20percent increase in sum of diameters of target lesions.

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