NCT06294548

A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC

A Phase Ib/II, Dose Escalation and Dose Expansion Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in Advanced Hepatocellular Carcinoma (HCC)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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/kg IV on day 1 of each cycle. Each cycle is 21 days. Atezolizumab and bevacizumab will be administered based on institutional guidelines and practice at the FDA approved dosages and intervals for advanced HCC. Valemetostat should be taken immediately prior to the start of atezolizumab and bevacizumab infusion on day 1 of each cycle.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Valemetostat	Valemetostat is an inhibitor of the enzymes enhancer of zeste homolog 1 (EZH1) and enhancer of zeste homolog 2 (EZH2).
DRUG	Atezolizumab	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.
DRUG	Bevacizumab	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.

Timeline

• Start date: 2025-07-29
• Primary completion: 2028-01-30
• Completion: 2028-08-28
• First posted: 2024-03-05
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study