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A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Trial Status: active
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.
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
Additional locations may be listed on ClinicalTrials.gov for NCT06600321.
