RecruitingHepatocellular Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

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.

Sponsor: University of Alabama at Birmingham

You may qualify if…

✓ 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 received prior liver directed therapy (ie., Trans arterial chemoembolization \[TACE\], Y-90, liver directed radiation etc.) are eligible provided the target lesion(s) have not been previously treated with liver directed therapy or the target lesion(s) within the field of local therapy have subsequently progressed in accordance with RECIST v1.1 (See Section 12)
✓ 5. Locally advanced, metastatic, or unresectable disease.
✓ 6. No prior systemic therapy for advanced HCC.
✓ 7. Child Pugh Class A.

You may not qualify if…

✕ Subjects who meet any of the following criteria will be disqualified from entering the study:
✕ 1. Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:
✕ Pregnant persons
✕ Nursing persons
✕ Persons of childbearing potential who are unwilling to employ adequate contraception
✕ 2. Liver directed therapy (Trans arterial chemoembolization \[TACE\], Y-90, liver directed radiation, etc.) ≤ 28 days prior to registration.
✕ 3. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
✕ 4. Uncontrolled or significant cardiovascular disease, including the following:

Where it's recruiting

Alabama

Birmingham

Source: ClinicalTrials.gov · NCT06294548 · last updated 2025-08-11