Status:
RECRUITING
DRP-104 (Glutamine Antagonist) in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Dracen Pharmaceuticals, Inc.
Fibrolamellar Cancer Foundation
Conditions:
Fibrolamellar Hepatocellular Carcinoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief 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 measu...
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
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06027086
Start Date
February 12 2024
End Date
September 1 2033
Last Update
December 3 2025
Active Locations (1)
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1
Johns Hopkins SKCCC
Baltimore, Maryland, United States, 21231