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A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- ALN-BCAT (drug)
- Pembrolizumab (drug)
Sponsor: Alnylam Pharmaceuticals · Participants: 158 · Started: Dec 30, 2024
Contact the study team
- Alnylam Clinical Trial Information Line · Phone: 1-877-ALNYLAM
- Alnylam Clinical Trial Information Line · Phone: 1-877-256-9526
Official record on ClinicalTrials.gov — NCT06600321
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.