Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06600321

A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Led by Alnylam Pharmaceuticals · Updated on 2026-05-01

158

Participants Needed

23

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria for patients with liver cirrhosis as per AASLD guidelines
  • Received at least one prior systemic therapy for unresectable advanced or metastatic disease
  • Presence of at least one WNT-pathway activating mutation
  • Classified as Child-Pugh class A or B7
Not Eligible

You will not qualify if you...

  • Diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
  • Presence of symptomatic extrahepatic disease
  • Received anti-cancer therapy or investigational drugs within 3 weeks before the first dose of study drug
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 23 locations

1

Clinical Trial Site

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Clinical Trial Site

La Jolla, California, United States, 92037

Actively Recruiting

3

Clinical Trial Site

Los Angeles, California, United States, 90033

Actively Recruiting

4

Clinical Trial Site

Jacksonville, Florida, United States, 32224

Actively Recruiting

5

Clinical Trial Site

Atlanta, Georgia, United States, 30322

Actively Recruiting

6

Clinical Trial Site

Chicago, Illinois, United States, 60637

Actively Recruiting

7

Clinical Trial Site

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

8

Clinical Trial Site

Rochester, Minnesota, United States, 55905

Actively Recruiting

9

Clinical Trial Site

New York, New York, United States, 10029

Actively Recruiting

10

Clinical Trial Site

New York, New York, United States, 10032

Actively Recruiting

11

Clinical Trial Site

Cleveland, Ohio, United States, 44106

Actively Recruiting

12

Clinical Trial Site

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

13

Clinical Trial Site

Dallas, Texas, United States, 75390

Actively Recruiting

14

Clinical Trial Site

Houston, Texas, United States, 77030

Actively Recruiting

15

Clinical Trial Site

San Antonio, Texas, United States, 78229

Actively Recruiting

16

Clinical Trial Site

Richmond, Virginia, United States, 23298

Actively Recruiting

17

Clinical Trial Site

Milan, Italy, 20132

Actively Recruiting

18

Clinical Trial Site

Rozzano, Italy, 20089

Actively Recruiting

19

Clinical Trial Site

Verona, Italy, 37134

Actively Recruiting

20

Clinical Trial Site

Busan, South Korea, 49241

Actively Recruiting

21

Clinical Trial Site

Seongnam, South Korea, 13496

Actively Recruiting

22

Clinical Trial Site

Seongnam, South Korea, 13620

Actively Recruiting

23

Clinical Trial Site

Seoul, South Korea, 03722

Actively Recruiting

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Research Team

A

Alnylam Clinical Trial Information Line

CONTACT

A

Alnylam Clinical Trial Information Line

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma | DecenTrialz