A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

ALN-BCAT: Administered by intravenous (IV) infusion

Pembrolizumab: Administered by intravenous (IV) infusion

Study 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.

Eligibility

Primary outcome measure(s)

• Frequency of Adverse Events (AEs) — From the time of first dose of study drug administration to 30-37 days after the last dose
• Severity of AEs — 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) — 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) — Up to 30-37 Days after the last dose

Trial sites (23)

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