> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-aln-bcat-in-patients-with-hepatocellular-0368d6ce-51b1-42ea-ae10-ac2d51a00d46 > Record changed: 2026-10-13 # A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma NCT06600321 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) Participants 158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) Lead sponsor Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) Start date 2024-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) Number of sites 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Short title** A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Official title** 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](https://clinicaltrials.gov/study/NCT06600321) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Dates **Completion date** 2027-10-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **First posted** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Registry last updated** 2026-06-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Primary completion date** 2027-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Start date** 2024-12-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Size and sites **Participants** 158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Planned participants** 158 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Number of sites** 23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Lead sponsor** Alnylam Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Identifiers **Registry ID** NCT06600321 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **ClinicalTrials.gov ID** NCT06600321 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Outcomes ### Primary outcomes 1. Frequency of Adverse Events (AEs) Timeframe: From the time of first dose of study drug administration to 30-37 days after the last dose 2. Severity of AEs Timeframe: From the time of first dose of study drug administration to 30-37 days after the last dose 3. Dose Escalation: Occurrence of Dose-limiting Toxicities (DLTs) Timeframe: From the time of first dose of study drug administration up to 21 days 4. Dose Expansion: Antitumor Activity as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Timeframe: Up to 30-37 Days after the last dose ### Secondary outcomes 1. Concentrations of ALN-BCAT in Plasma Timeframe: Up to the end of the last study drug administration Area Under the Plasma Concentration-time Curve (AUC), Maximum Observed Plasma Concentration (Cmax) Time to Maximum Plasma Concentration (Tmax) 2. Percent Change in Gene that Encodes ß-catenin Protein (CTNNB1) Messenger Ribonucleic Acid (mRNA) Expression Comparing Pre- treatment with On-treatment Tumor Samples Timeframe: Up to 30 days 3. Dose Escalation: Antitumor Activity as assessed by RECIST v1.1 Timeframe: Up to 30-37 Days after the last dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Sites - Clinical Trial SitePhoenix, United StatesRecruiting - Clinical Trial SiteLa Jolla, United StatesRecruiting - Clinical Trial SiteLos Angeles, United StatesRecruiting - Clinical Trial SiteJacksonville, United StatesRecruiting - Clinical Trial SiteAtlanta, United StatesRecruiting - Clinical Trial SiteChicago, United StatesRecruiting - Clinical Trial SiteAnn Arbor, United StatesRecruiting - Clinical Trial SiteRochester, United StatesRecruiting - Clinical Trial SiteNew York, United StatesRecruiting - Clinical Trial SiteNew York, United StatesCompleted - Clinical Trial SiteCleveland, United StatesRecruiting - Clinical Trial SitePittsburgh, United StatesRecruiting - Clinical Trial SiteDallas, United StatesRecruiting - Clinical Trial SiteHouston, United StatesRecruiting - Clinical Trial SiteSan Antonio, United StatesRecruiting - Clinical Trial SiteRichmond, United StatesRecruiting - Clinical Trial SiteMilan, ItalyRecruiting - Clinical Trial SiteRozzano, ItalyRecruiting - Clinical Trial SiteVerona, ItalyRecruiting - Clinical Trial SiteBusan, South KoreaRecruiting - Clinical Trial SiteSeongnam, South KoreaRecruiting - Clinical Trial SiteSeongnam, South KoreaRecruiting - Clinical Trial SiteSeoul, South KoreaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06600321) ## Related records ### Drugs (1) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Alnylam Pharmaceuticals](https://trialight.com/data/company/alnylam-pharmaceuticals-37379b27-2f42-476c-879b-9773955a515f.md) ### Conditions (3) - [Hepatocellular carcinoma](https://trialight.com/data/condition/hepatocellular-carcinoma-fc1014ac-5a3c-551d-98ea-95306009e299.md) Primary condition - [Liver and intrahepatic bile duct neoplasm](https://trialight.com/data/condition/liver-and-intrahepatic-bile-duct-neoplasm-3f40b188-18f7-5f55-8a6b-3ab9293211bd.md) - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) ### Targets (1) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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