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Trial Title:
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
NCT ID:
NCT06600321
Condition:
Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Pembrolizumab
Conditions: Keywords:
Hepatocellular carcinoma (HCC)
Pembrolizumab
CTNNB1
Liver disease
Liver cancer
Liver neoplasms
Carcinoma, hepatocellular
WNT pathway activating
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ALN-BCAT
Description:
Administered by intravenous (IV) infusion
Arm group label:
Combination Therapy: Dose Escalation
Arm group label:
Combination Therapy: Dose Expansion
Arm group label:
Monotherapy: Dose Escalation
Arm group label:
Monotherapy: Dose Expansion
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered by intravenous (IV) infusion
Arm group label:
Combination Therapy: Dose Escalation
Arm group label:
Combination Therapy: Dose Expansion
Other name:
Keytruda
Other name:
MK-3475
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Start date:
October 31, 2024
Completion date:
October 31, 2027
Lead sponsor:
Agency:
Alnylam Pharmaceuticals
Agency class:
Industry
Source:
Alnylam Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06600321
