A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
NCT06600321 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 158
Last updated 2026-05-01
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.
Conditions
- Advanced Hepatocellular Carcinoma
- Metastatic Hepatocellular Carcinoma
Interventions
- DRUG
-
ALN-BCAT
Administered by intravenous (IV) infusion
- DRUG
-
Administered by intravenous (IV) infusion
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Alnylam Pharmaceuticals
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-30
- Primary Completion
- 2027-09-30
- Completion
- 2027-10-31
- FDA Drug
- Yes
Countries
- United States
- Italy
- South Korea
Study Locations
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