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

NCT06294548 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-08-11

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Mehmet Akce, MD · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2028-01-30
Completion
2028-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06294548 on ClinicalTrials.gov