Actively Recruiting
A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC
Led by University of Alabama at Birmingham · Updated on 2025-08-11
45
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years of age or older
- Confirmed diagnosis of hepatocellular carcinoma by histology, cytology, or clinical criteria
- At least one measurable untreated lesion per RECIST v1.1
- Locally advanced, metastatic, or unresectable disease
- No prior systemic therapy for advanced HCC
- Child Pugh Class A liver function
- Barcelona Clinic Liver Cancer Stage B (not amenable to liver directed therapy) or Stage C
- ECOG Performance Status of 0 or 1
- Laboratory values within specified limits including ANC 200/mm3, platelets 100,000/mm3, hemoglobin 9.0 g/dL, bilirubin 1.5 x ULN, ALT and AST 3 x ULN, and creatinine clearance 40 mL/min
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception
- Willingness to provide informed consent and comply with study follow-up and blood specimen collection
- Stable unresolved toxicities from prior anticancer therapy allowed if Grade 1 or baseline, chronic stable Grade 2 toxicities may be included
You will not qualify if you...
- Pregnant or nursing persons or those unwilling to use adequate contraception
- Liver directed therapy within 28 days prior to registration
- Severe concurrent illnesses or systemic diseases interfering with study participation
- Uncontrolled cardiovascular diseases including recent myocardial infarction, uncontrolled angina, or severe heart failure
- Active malignancy within past 3 years except certain curable cancers
- Prior treatment with EZH inhibitors
- Use of certain CYP3A inducers or inhibitors during dose escalation phase
- Immunocompromised patients or HIV positive on antiretroviral therapy
- Active hepatitis B or C infection not controlled by therapy
- Ongoing uncontrolled infections requiring intravenous treatment
- Serious physical or psychiatric diseases increasing study risk
- Recent significant bleeding or clotting disorders
- Recent use of certain anticoagulants or antiplatelet drugs
- Recent biopsy or surgical procedures within defined timeframes
- History of gastrointestinal fistulas, perforations, or obstructions within 6 months
- Non-healing wounds, active ulcers, or untreated fractures
- Metastatic disease affecting major airways or blood vessels
- Recent radiotherapy or major surgery within specified intervals
- Chronic daily use of NSAIDs (occasional use allowed)
- Known fibrolamellar carcinoma, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma
- Untreated or high-risk varices for bleeding without prior treatment
- History of organ transplantation
- Active or prior autoimmune or inflammatory disorders with some exceptions
- History of brain metastases or leptomeningeal carcinomatosis
- Allergy to study drugs or their components
- Recent use of immunosuppressive medications except certain low-dose steroids
- Receipt of live attenuated vaccines within 30 days prior to registration
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
Research Team
M
Margaret Thomas, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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