RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-11-30
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06600321

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Has had at least one line of systemic therapy for unresectable advanced or metastatic disease
  3. * Has at least one wingless-related integration site (WNT)-pathway activating mutation
  4. * Child-Pugh class A or B7
  1. * Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
  2. * Has symptomatic extrahepatic disease
  3. * Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug

Contacts and Locations

Study Contact

Alnylam Clinical Trial Information Line
CONTACT
1-877-ALNYLAM
clinicaltrials@alnylam.com
Alnylam Clinical Trial Information Line
CONTACT
1-877-256-9526
clinicaltrials@alnylam.com

Principal Investigator

Medical Director
STUDY_DIRECTOR
Alnylam Pharmaceuticals

Study Locations (Sites)

MD Anderson
Houston, Texas, 77030
United States
Clinical Trial Site
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Alnylam Pharmaceuticals

  • Medical Director, STUDY_DIRECTOR, Alnylam Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-30
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2024-11-30
Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

  • Hepatocellular carcinoma (HCC)
  • Pembrolizumab
  • CTNNB1
  • Liver disease
  • Liver cancer
  • Liver neoplasms
  • Carcinoma, hepatocellular
  • WNT pathway activating

Additional Relevant MeSH Terms

  • Advanced Hepatocellular Carcinoma
  • Metastatic Hepatocellular Carcinoma