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A Study of Valemetostat, Atezolizumab, and Bevacizumab for Advanced Liver Cancer

This study is testing a new combination of medicines for people with advanced hepatocellular carcinoma (HCC), a type of liver cancer, who haven't had prior systemic treatment. You would receive valemetostat, which works by blocking certain enzymes (EZH1 and EZH2), along with atezolizumab and bevacizumab. Atezolizumab and bevacizumab are already approved for advanced HCC. The study aims to see how safe and effective this new combination is. Researchers will monitor your progress for up to 36 months. The study is currently recruiting up to 45 participants.

Study design
This is a phase Ib/II study, meaning it looks at both safety and effectiveness, with about 45 participants. It is a dose escalation and dose expansion study.
What's involved
You would take valemetostat daily by mouth and receive atezolizumab and bevacizumab intravenously (through an IV) every 21 days. You would have scans every 9 weeks and may have research biopsies.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured for up to 36 months after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06294548

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Alabama at Birmingham
~45 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:ValemetostatAtezolizumabBevacizumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1b
Measured over Baseline up to 36 months
+1 more outcome measured

Conditions

Hepatocellular Carcinoma

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Hepatocellular CarcinomaHepatitis B Infection

NCT06294548

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Alabama at Birmingham

    Birmingham, Alabamastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Mehmet Akce, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Margaret Thomas, MPH
[email protected]
205-895-1802
Email the study team

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Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥1500/mm3
Platelet count 100,000/mm3 (platelet transfusion is not allowed within 14 days prior to screening assessment).
Hemoglobin (Hgb) 9.0 g/dL (red blood cell transfusion is not allowed within 14 days prior to screening assessment).
Total bilirubin (TBIL) ≤1.5 x ULN.
ALT and AST ≤3 x ULN
For patients not receiving therapeutic anticoagulation INR or aPTT ≤2 x ULN
Creatinine clearance ≥40 mL/min (measured by the Cockcroft-Gault equation) 11. If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control, as detailed in Section 4.4, upon enrollment, during the Treatment Period, and for 6 months, following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy or bilateral oophorectomy) with surgery at least 1 month before the first dose of study drug or confirmed by follicle stimulating hormone (FSH) test \>40 mIU/mL and estradiol \<40 pg/mL (\<140 pmol/L).
Hypothyroidism/ hyperthyroidism.
Type I diabetes.
Hyperglycemia.
Adrenal insufficiency.
Adrenalitis.
Skin hypopigmentation (vitiligo).

Exclusion

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:
Evidence of prolongation of QT/QTc interval (eg, repeated episodes of QT corrected for heart rate using Fridericia's method \[QTcF\] \>470 ms) (average of triplicate determinations)
Myocardial infarction within 6 months prior to Screening
Uncontrolled angina pectoris within 6 months prior to Screening
New York Heart Association (NYHA) Class 3 or 4 congestive heart failure
Inadequately controlled hypertension (defined as systolic blood pressure ≥150 mmHg and/or diastolic blood pressure \>100 mmHg, based on average ≥3 blood pressure readings on ≥2 sessions. Anti-hypertensive therapy to achieve these parameters is allowed. 5. Prior malignancy active within the previous 3 years except for locally curable cancer that is currently considered as cured, such as cutaneous basal or squamous cell carcinoma, superficial bladder cancer, or cervical carcinoma in situ, or an incidental histological finding of prostate cancer. 6. History of treatment with other EZH inhibitors 7. Current use of moderate or strong cytochrome P450 (CYP)3A inducers, and strong CYP3A and/or P-gp inhibitors in dose escalation phase (See Table 11). 8. Immunocompromised patients and patients known to be Human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy or known acquired immunodeficiency syndrome. 9. Regarding hepatitis B, patients must meet the following criteria to be eligible:
Patients with vitiligo or alopecia
Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Patients without active disease in the last 5 years may be included but only after consultation with the study physician
Patients with celiac disease controlled by diet alone 32. History of leptomeningeal carcinomatosis or intracranial metastases 33. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 34. Current or prior use of immunosuppressive medication ≤ 14 days prior to registration. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) 35. Receipt of live attenuated vaccine ≤30 days prior to registration. Note: Patients, if enrolled, should not receive live vaccine whilst on study treatment and up to 30 days after the last dose of study treatment.

What this trial measures

  • Phase 1bBaseline up to 36 months

    Evaluate the safety, tolerability, and MTD/RP2D of valemetostat when administered with atezolizumab and bevacizumab in advanced HCC (phase 1b).

  • Phase IIBaseline up to 36 months

    Estimate the objective response rate (ORR) by RECIST version 1.1. per investigator assessment for valemetostat when administered with atezolizumab and bevacizumab at RP2D in advanced HCC (phase II).