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Monoclonal Antibodies

Valemetostat + Atezolizumab + Bevacizumab for Liver Cancer

Phase 1 & 2
Waitlist Available
Led By Mehmet S Akce, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 48 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination treatment for advanced liver cancer patients who have not received prior systemic therapy. The treatment includes valemetostat, atezolizumab, and bevaciz

Who is the study for?
This trial is for adults with advanced Hepatocellular carcinoma (HCC) who haven't had systemic therapy for their condition. Details on specific inclusion and exclusion criteria are not provided, but typically participants need to meet certain health standards.
What is being tested?
The study tests valemetostat combined with atezolizumab and bevacizumab in treating liver cancer. It's a two-part trial: first, finding the right dose of valemetostat (dose escalation), then seeing how well it works at that dose (dose expansion).
What are the potential side effects?
While specific side effects aren't listed here, common ones for cancer treatments like these may include fatigue, nausea, increased risk of infection, bleeding issues due to bevacizumab, and possible immune-related reactions from atezolizumab.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1b
Phase II
Secondary study objectives
Disease Control Rate (DCR)
Duration of response (DoR)
Overall survival (OS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase II: Valemetostat + Atezolizumab 1200 mg + Bevacizumab 15 mg/kgExperimental Treatment3 Interventions
During Phase II, study participants will receive valemetostat (DS-3201) orally daily at MTD/RP2D, plus atezolizumab 1200 mg intravenously (IV) on day 1, and bevacizumab 15 mg/kg IV on day 1 of each cycle.
Group II: Phase 1b: Valemetostat + Atezolizumab 1200 mg + Bevacizumab 15 mg/kgExperimental Treatment3 Interventions
In Phase 1b 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. During Phase 1b, a 3+3 dose escalation design will be utilized to define the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) with starting dose of valemetostat 150mg by mouth daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,656 Previous Clinical Trials
2,444,330 Total Patients Enrolled
1 Trials studying Liver Cancer
5 Patients Enrolled for Liver Cancer
Mehmet S Akce, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
~30 spots leftby Nov 2027