A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Recruiting now · Phase 1
Conditions studied: Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
In brief
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.
Key facts
- Study ID
- NCT06600321
- Run by
- Alnylam Pharmaceuticals
- People needed
- 158
- Starts
- 2024-12-30
- Expected to finish
- 2027-10-31
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- Note: other protocol defined inclusion / exclusion criteria apply
Where it is running
- Clinical Trial Site — Seoul, South Korea (enrolling)
- Clinical Trial Site — La Jolla, California, United States (enrolling)
- Clinical Trial Site — Los Angeles, California, United States (enrolling)
- Clinical Trial Site — Jacksonville, Florida, United States (enrolling)
- Clinical Trial Site — Atlanta, Georgia, United States (enrolling)
- Clinical Trial Site — Chicago, Illinois, United States (enrolling)
- Clinical Trial Site — Ann Arbor, Michigan, United States (enrolling)
- Clinical Trial Site — Rochester, Minnesota, United States (enrolling)
- Clinical Trial Site — New York, New York, United States (enrolling)
- Clinical Trial Site — Phoenix, Arizona, United States (enrolling)
- Clinical Trial Site — Cleveland, Ohio, United States (enrolling)
- Clinical Trial Site — Pittsburgh, Pennsylvania, United States (enrolling)
- Clinical Trial Site — Dallas, Texas, United States (enrolling)
- Clinical Trial Site — Houston, Texas, United States (enrolling)
- Clinical Trial Site — San Antonio, Texas, United States (enrolling)
- Clinical Trial Site — Richmond, Virginia, United States (enrolling)
- Clinical Trial Site — Milan, Italy (enrolling)
- Clinical Trial Site — Rozzano, Italy (enrolling)
- Clinical Trial Site — Verona, Italy (enrolling)
- Clinical Trial Site — Busan, South Korea (enrolling)
- Clinical Trial Site — Seongnam, South Korea (enrolling)
- Clinical Trial Site — Seongnam, South Korea (enrolling)
- Clinical Trial Site — New York, New York, United States
Full record on ClinicalTrials.gov
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