A Phase 1b/2 Study of Glutamine Antagonist DRP-104 in Combination With Durvalumab in Patients With Advanced Stage Fibrolamellar Hepatocellular Carcinoma (FLC)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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).
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * P…
Interventions
- DrugDurvalumab
Patients will receive treatment on Day 1 of each cycle. Durvalumab (1500 mg) will be administered IV on Day 1 of each cycle every 28 days.
- DrugDRP-104
Patients will receive treatment twice a week of each cycle. DRP-104 (145 mg,125mg, 105mg, 85mg or 65mg) will be administered subcutaneous injection twice a week of each 28 day cycle. After the first cycle of treatment the study drug may be shipped to the patient's home for future cycles of administration if patients or caregiver can demonstrate at least two observed independent injections of DRP-104 prior to home administration.
Location
- Johns Hopkins SKCCCBaltimore, Maryland