A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Clinical Trial Site
RECRUITING
Phoenix
California
Clinical Trial Site
RECRUITING
Los Angeles
Clinical Trial Site
RECRUITING
San Diego
Florida
Clinical Trial Site
RECRUITING
Jacksonville
Georgia
Clinical Trial Site
RECRUITING
Atlanta
Illinois
Clinical Trial Site
RECRUITING
Chicago
Michigan
Clinical Trial Site
RECRUITING
Ann Arbor
Minnesota
Clinical Trial Site
RECRUITING
Rochester
New York
Clinical Trial Site
RECRUITING
New York
Clinical Trial Site
RECRUITING
New York
Ohio
Clinical Trial Site
RECRUITING
Cleveland
Pennsylvania
Clinical Trial Site
RECRUITING
Pittsburgh
Texas
Clinical Trial Site
RECRUITING
Dallas
Clinical Trial Site
RECRUITING
Houston
Clinical Trial Site
RECRUITING
San Antonio
Virginia
Clinical Trial Site
RECRUITING
Richmond
Other Locations
Italy
Clinical Trial Site
RECRUITING
Verona
Republic of Korea
Clinical Trial Site
RECRUITING
Busan
Clinical Trial Site
RECRUITING
Seongnam-si
Clinical Trial Site
RECRUITING
Seoul
Contact Information
Primary
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-ALNYLAM
Backup
Alnylam Clinical Trial Information Line
clinicaltrials@alnylam.com
1-877-256-9526
Time Frame
Start Date:2024-12-30
Estimated Completion Date:2027-10-31
Participants
Target number of participants:158
Treatments
Experimental: Monotherapy: Dose Escalation
Patients will be administered multiple doses of ALN-BCAT.
Experimental: Monotherapy: Dose Expansion
Patients will be administered multiple doses of ALN-BCAT.