RecruitingPhase 1NCT06600321

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

Sponsor

Alnylam Pharmaceuticals

Enrollment

158 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Hepatocellular Carcinoma Advanced Hepatocellular Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called ALN-BCAT in patients with advanced liver cancer (hepatocellular carcinoma, or HCC) whose tumour has a specific genetic mutation in the WNT pathway — a signalling system involved in cancer growth. **You may be eligible if...** - You have been diagnosed with hepatocellular carcinoma (liver cancer), confirmed by biopsy, lab tests, or standard imaging criteria - Your cancer is advanced or has spread and is not suitable for surgery - You have already received at least one prior systemic (whole-body) treatment - Your tumour has a WNT-pathway activating mutation (identified by genetic testing) - Your liver function is relatively preserved (Child-Pugh class A or B7) **You may NOT be eligible if...** - You have a rare subtype of liver cancer (fibrolamellar, sarcomatoid, or mixed cholangio-HCC) - You have symptoms from cancer that has spread outside the liver - You received cancer treatment or an investigational drug within the last 3 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALN-BCAT

Administered by intravenous (IV) infusion

DRUGPembrolizumab

Administered by intravenous (IV) infusion

Locations(23)

Clinical Trial Site

Phoenix, Arizona, United States

Clinical Trial Site

La Jolla, California, United States

Clinical Trial Site

Los Angeles, California, United States

Clinical Trial Site

Jacksonville, Florida, United States

Clinical Trial Site

Atlanta, Georgia, United States

Clinical Trial Site

Chicago, Illinois, United States

Clinical Trial Site

Ann Arbor, Michigan, United States

Clinical Trial Site

Rochester, Minnesota, United States

Clinical Trial Site

New York, New York, United States

Clinical Trial Site

New York, New York, United States

Clinical Trial Site

Cleveland, Ohio, United States

Clinical Trial Site

Pittsburgh, Pennsylvania, United States

Clinical Trial Site

Dallas, Texas, United States

Clinical Trial Site

Houston, Texas, United States

Clinical Trial Site

San Antonio, Texas, United States

Clinical Trial Site

Richmond, Virginia, United States

Clinical Trial Site

Milan, Italy

Clinical Trial Site

Rozzano, Italy

Clinical Trial Site

Verona, Italy

Clinical Trial Site

Busan, South Korea

Clinical Trial Site

Seongnam, South Korea

Clinical Trial Site

Seongnam, South Korea

Clinical Trial Site

Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06600321

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