NCT06600321RecruitingPhase 1
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 158 (estimated)
- First submitted
- 13 Sept 2024
- Start date
- 30 Dec 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Alnylam Pharmaceuticals
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06600321
- EU CT number
- 2024-519499-22-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 158
- From 30 Dec 2024 to the primary completion date, 30 Sept 2027
- 21 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Has symptomatic extrahepatic disease
Other
- Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.