A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
NCT ID: NCT06600321
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
158 participants
INTERVENTIONAL
2024-12-30
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Monotherapy: Dose Escalation
Patients will be administered multiple doses of ALN-BCAT.
ALN-BCAT
Administered by intravenous (IV) infusion
Monotherapy: Dose Expansion
Patients will be administered multiple doses of ALN-BCAT.
ALN-BCAT
Administered by intravenous (IV) infusion
Combination Therapy: Dose Escalation
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
ALN-BCAT
Administered by intravenous (IV) infusion
Pembrolizumab
Administered by intravenous (IV) infusion
Combination Therapy: Dose Expansion
Patients will be administered multiple doses of ALN-BCAT in combination with pembrolizumab.
ALN-BCAT
Administered by intravenous (IV) infusion
Pembrolizumab
Administered by intravenous (IV) infusion
Interventions
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ALN-BCAT
Administered by intravenous (IV) infusion
Pembrolizumab
Administered by intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* Has symptomatic extrahepatic disease
* Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug
18 Years
ALL
No
Sponsors
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Alnylam Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Alnylam Pharmaceuticals
Locations
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Clinical Trial Site
Phoenix, Arizona, United States
Clinical Trial Site
Los Angeles, California, United States
Clinical Trial Site
San Diego, 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
Verona, , Italy
Clinical Trial Site
Busan, , South Korea
Clinical Trial Site
Seongnam-si, , South Korea
Clinical Trial Site
Seoul, , South Korea
Countries
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Central Contacts
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Alnylam Clinical Trial Information Line
Role: CONTACT
Phone: 1-877-256-9526
Email: [email protected]
Other Identifiers
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ALN-BCAT-001
Identifier Type: -
Identifier Source: org_study_id