A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlnylam Pharmaceuticals
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ALN-BCAT
- Pembrolizumab
Treatment groups
158 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov