NCT06600321

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ALN-BCAT	Administered by intravenous (IV) infusion
DRUG	Pembrolizumab	Administered by intravenous (IV) infusion

Timeline

• Start date: 2024-12-30
• Primary completion: 2027-09-30
• Completion: 2027-10-31
• First posted: 2024-09-19
• Last updated: 2026-03-31

Locations

23 sites across 3 countries: United States, Italy, South Korea

Regulatory

• FDA-regulated drug study