Study on DRP-104 and Durvalumab Combination for Advanced Fibrolamellar Carcinoma

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06027086

Provider View

This clinical trial is testing a new treatment combining DRP-104 and Durvalumab to see if it is safe and effective in treating advanced fibrolamellar carcinoma (FLC). The study will measure how well the treatment works by looking at tumor response, progression-free survival, and overall survival.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new combination of treatments, DRP-104 and Durvalumab, is safe and effective for patients with advanced fibrolamellar carcinoma (FLC). Researchers will evaluate the treatment's ability to shrink tumors and improve survival rates. Participants will receive DRP-104 as a subcutaneous injection and Durvalumab through an intravenous infusion.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of fibrolamellar carcinoma (FLC) that has spread or cannot be removed by surgery.
  • Have a specific genetic marker called DNAJB1-PRKACA fusion in the tumor.
  • Showed cancer progression on previous or current immunotherapy.
  • Be 12 years or older.
  • If under 18, must weigh at least 40 kg.
  • Be in good overall health with an ECOG performance status of 0, 1, or 2.
  • Have adequate organ and bone marrow function based on lab tests.
  • Have adequate kidney and liver function based on lab tests.
  • Have measurable cancer according to standard criteria.
  • Agree to provide tissue and blood samples for research.
  • Women of childbearing potential must have a negative pregnancy test.
  • Both men and women must use effective birth control during the study.
  • Be able to understand and sign a consent form.

Exclusion Criteria

  • Have had chemotherapy, other cancer treatments, or radiation within 21 days before starting the study treatment.
  • Have had surgery within 28 days before starting the study treatment, except for minor procedures.
  • Have taken other investigational drugs or devices within 21 days before starting the study treatment.
  • Have not recovered from previous treatment side effects, except for certain manageable conditions.
  • Have a heart condition with a prolonged QT interval on an ECG.
  • Are taking certain medications that affect liver enzymes and cannot stop them 14 days before starting the study.
  • Have allergies to similar drugs as DRP-104 or Durvalumab.
  • Have lung disease that could interfere with the study.
  • Have low oxygen levels or need home oxygen.
  • Have untreated or active brain cancer spread.
  • Have uncontrolled medical or psychiatric conditions.
  • Are pregnant or breastfeeding.
  • Have HIV/AIDS.
  • Have active hepatitis B.
  • Have had recent severe digestive issues.
  • Are unable or unwilling to follow the study schedule.
  • Use illicit drugs or have a history of substance abuse.
  • Have fluid buildup in the abdomen (ascites).
  • Have had severe reactions to similar cancer treatments.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have had a stem cell or organ transplant.
  • Have an immune deficiency.
  • Are taking high-dose steroids.

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