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A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Sponsor: Alnylam Pharmaceuticals
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.
Official title: A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
158
Start Date
2024-12-30
Completion Date
2027-10-31
Last Updated
2026-03-31
Healthy Volunteers
No
Interventions
ALN-BCAT
Administered by intravenous (IV) infusion
Pembrolizumab
Administered by intravenous (IV) infusion
Locations (23)
Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
La Jolla, California, United States
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Los Angeles, California, United States
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Jacksonville, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Ann Arbor, Michigan, United States
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Rochester, Minnesota, United States
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New York, New York, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Milan, Italy
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Rozzano, Italy
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Verona, Italy
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Busan, South Korea
Clinical Trial Site
Seongnam, South Korea
Clinical Trial Site
Seongnam, South Korea
Clinical Trial Site
Seoul, South Korea