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

Conditions

• Fibrolamellar Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Durvalumab — DRUG
  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.
• DRP-104 — DRUG
  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.

Study Details

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).

Key Dates

Start date

Feb 12, 2024

Status verified

Feb 2026

Primary completion

Sep 1, 2028

Completion

Sep 1, 2033

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Durvalumab and DRP-104

Primary Outcome Measure

Number of participants experiencing drug-related adverse events (AEs) requiring treatment discontinuation [ Time Frame: 4 years ]

Central Contacts

• Colleen Apostal, RN
  410-614-3644
  [email protected]

Locations (1)

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