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

Description

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

Study Overview

Study Details

Study overview

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.

A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma

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

Condition
Advanced Hepatocellular Carcinoma
Intervention / Treatment

-

Contacts and Locations

Houston

MD Anderson, Houston, Texas, United States, 77030

San Antonio

Clinical Trial Site, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alnylam Pharmaceuticals,

Medical Director, STUDY_DIRECTOR, Alnylam Pharmaceuticals

Study Record Dates

2027-10-31