Status:
RECRUITING
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Lead Sponsor:
Alnylam Pharmaceuticals
Conditions:
Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT06600321
Start Date
December 30 2024
End Date
October 31 2027
Last Update
December 24 2025
Active Locations (23)
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1
Clinical Trial Site
Phoenix, Arizona, United States, 85054
2
Clinical Trial Site
La Jolla, California, United States, 92037
3
Clinical Trial Site
Los Angeles, California, United States, 90033
4
Clinical Trial Site
Jacksonville, Florida, United States, 32224