A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ALN-BCAT, Pembrolizumab.
- Who it may be relevant to
- Registry conditions: Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma
Overview
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.
Interventions
- Drug ALN-BCAT
Administered by intravenous (IV) infusion - Drug Pembrolizumab
Administered by intravenous (IV) infusion
Primary outcome measures
- Frequency of Adverse Events (AEs) [Time frame: From the time of first dose of study drug administration to 30-37 days after the last dose]
- Severity of AEs [Time frame: From the time of first dose of study drug administration to 30-37 days after the last dose]
- Dose Escalation: Occurrence of Dose-limiting Toxicities (DLTs) [Time frame: From the time of first dose of study drug administration up to 21 days]
- Dose Expansion: Antitumor Activity as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) [Time frame: Up to 30-37 Days after the last dose]
Secondary outcome measures (3)
- Concentrations of ALN-BCAT in Plasma [Time frame: Up to the end of the last study drug administration]
- Percent Change in Gene that Encodes ß-catenin Protein (CTNNB1) Messenger Ribonucleic Acid (mRNA) Expression Comparing Pre- treatment with On-treatment Tumor Samples [Time frame: Up to 30 days]
- Dose Escalation: Antitumor Activity as assessed by RECIST v1.1 [Time frame: Up to 30-37 Days after the last dose]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 16 centers
- Clinical Trial Site — Phoenix
- Clinical Trial Site — La Jolla
- Clinical Trial Site — Los Angeles
- Clinical Trial Site — Jacksonville
- Clinical Trial Site — Atlanta
- Clinical Trial Site — Chicago
- Clinical Trial Site — Ann Arbor
- Clinical Trial Site — Rochester
- … and 8 more centers
South Korea · 4 centers
- Clinical Trial Site — Busan
- Clinical Trial Site — Seongnam
- Clinical Trial Site — Seongnam
- Clinical Trial Site — Seoul
Italy · 3 centers
- Clinical Trial Site — Milan
- Clinical Trial Site — Rozzano
- Clinical Trial Site — Verona
Identifiers
NCT: NCT06600321 · ALN-BCAT-001