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NCT06600321PHASE1Recruiting

A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Alnylam Pharmaceuticals

Start Date

12/30/2024

Completion Date

10/31/2027

Summary

The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria * Has had at least one line of systemic therapy for unresectable advanced or metastatic disease * Has at least one wingless-related integration site (WNT)-pathway activating mutation * Child-Pugh class A or B7 Exclusion Criteria: * Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors * Has symptomatic extrahepatic disease * Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug Note: other protocol defined inclusion / exclusion criteria apply

Interventions

DRUG

ALN-BCAT

DRUG

Pembrolizumab

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Conditions

Advanced Hepatocellular CarcinomaMetastatic Hepatocellular Carcinoma

Locations

Clinical Trial Site

Phoenix, Arizona 85054

United States

Clinical Trial Site

La Jolla, California 92037

United States

Clinical Trial Site

Los Angeles, California 90033

United States

Clinical Trial Site

Jacksonville, Florida 32224

United States

Clinical Trial Site

Atlanta, Georgia 30322

United States

Clinical Trial Site

Chicago, Illinois 60637

United States

Clinical Trial Site

Ann Arbor, Michigan 48109

United States

Clinical Trial Site

Rochester, Minnesota 55905

United States

Clinical Trial Site

New York, New York 10029

United States

Clinical Trial Site

New York, New York 10032

United States

Clinical Trial Site

Cleveland, Ohio 44106

United States

Clinical Trial Site

Pittsburgh, Pennsylvania 15232

United States

Clinical Trial Site

Dallas, Texas 75390

United States

Clinical Trial Site

Houston, Texas 77030

United States

Clinical Trial Site

San Antonio, Texas 78229

United States

Clinical Trial Site

Richmond, Virginia 23298

United States

Clinical Trial Site

Milan, 20132

Italy

Clinical Trial Site

Rozzano, 20089

Italy

Clinical Trial Site

Verona, 37134

Italy

Clinical Trial Site

Busan, 49241

South Korea

Clinical Trial Site

Seongnam, 13496

South Korea

Clinical Trial Site

Seongnam, 13620

South Korea

Clinical Trial Site

Seoul, 03722

South Korea