Study of Valemetostat Tosylate with Atezolizumab and Bevacizumab for Advanced Liver Cancer

Sponsor: University of Alabama at Birmingham

Sponsor score: 0

ClinicalTrials ID:NCT06294548

Provider View

This clinical trial is testing a new combination of drugs, including Valemetostat Tosylate, Atezolizumab, and Bevacizumab, to see if they can help treat advanced liver cancer in patients who have not received previous treatments for this condition.

Patient Parameters

Program Overview

The study aims to find out if a combination of Valemetostat Tosylate, Atezolizumab, and Bevacizumab can effectively treat advanced liver cancer (HCC) in patients who have not had prior systemic therapy. The trial will involve increasing doses to find the best amount to use and will include up to 45 patients over a period of up to 36 months.

Description

Participants in this study will take Valemetostat Tosylate daily by mouth and receive Atezolizumab and Bevacizumab through an IV on the first day of each 21-day cycle. The treatment will continue until the cancer progresses, side effects become too severe, or the participant decides to stop. Scans to check the cancer's response will be done every 9 weeks. The study will take place at UAB and aims to enroll about 45 patients over three years. Participants will also have biopsies taken for research purposes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced liver cancer (HCC).
  • Have at least one measurable tumor that has not been treated.
  • Have not received any prior systemic therapy for advanced HCC.
  • Have good liver function and overall health, as indicated by specific medical tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 6 months after.
  • Men must agree to use effective birth control during the study and for 6 months after.
  • Be willing to provide blood samples for research and return for follow-up visits.

Exclusion Criteria

  • Pregnant or breastfeeding women.
  • Recent liver-directed therapy within 28 days before starting the study.
  • Serious health conditions that could interfere with the study.
  • Uncontrolled heart disease or high blood pressure.
  • Active infections like hepatitis B or C, or HIV.
  • Recent use of certain medications that could interfere with the study drugs.
  • History of other cancers within the last 3 years, except for certain skin or localized cancers.
  • Recent major surgery or significant injuries.
  • Known allergies to the study drugs.
  • Use of immunosuppressive medications within 14 days before starting the study.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham35294BirminghamAlabama

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