A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)
University of Alabama at Birmingham
Summary
This is a phase Ib/II, dose escalation and dose expansion study of valemetostat (DS-3201) with atezolizumab and bevacizumab in patients advanced Hepatocellular carcinoma (HCC) who did not receive prior systemic therapy for advanced HCC.
Description
Patients will be started on valemetostat (DS-3201) with atezolizumab and bevacizumab, restaging scans will be performed every 9 weeks. The treatment will be continued until progressive disease (PD), unacceptable toxicity or consent withdrawal. Paired research biopsies will be performed. This study will enroll up to approximately 45-patients at UAB. It is estimated 2 patients will be enrolled per month over up to 36 months period. Patients will receive valemetostat (DS-3201) orally daily at their assigned dose level, plus atezolizumab 1200 mg intravenously (IV) on day 1, and bevacizumab 15 mg…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subjects must meet all the following criteria to be eligible for enrollment into the study: 1. Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures. 2. Subjects ≥18 years of age or the minimum legal adult age (whichever is greater) at the time the ICF is signed 3. HCC diagnosis confirmed by histology/cytology or clinically by American Association for Study of Liver Diseases (AASLD) 36 criteria in cirrhotic patients. 4. At least one measurable untreated lesion per RECIST v1.1 (see Section 12). Patients who receive…
Interventions
- DrugValemetostat
Valemetostat is an inhibitor of the enzymes enhancer of zeste homolog 1 (EZH1) and enhancer of zeste homolog 2 (EZH2).
- DrugAtezolizumab
Atezolizumab is commercially available. Atezolizumab combined with bevacizumab is approved for frontline treatment of advanced HCC based on IMbrave150 clinical trial. It will be administered as per the package insert and institutional standards.
- DrugBevacizumab
Bevacizumab is commercially available. Bevacizumab combined with atezolizumab is approved for frontline treatment of advanced HCC based on IMbrave150 clinical trial. It will be administered as per the package insert and institutional standards.
Location
- University of Alabama at BirminghamBirmingham, Alabama