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

Официальное название

A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma

Обзор

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.

Вмешательства

• Препарат ALN-BCAT
  Administered by intravenous (IV) infusion
• Препарат Pembrolizumab
  Administered by intravenous (IV) infusion

Первичные конечные точки

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

Вторичные конечные точки (3)

• Concentrations of ALN-BCAT in Plasma [Срок оценки: 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 [Срок оценки: Up to 30 days]
• Dose Escalation: Antitumor Activity as assessed by RECIST v1.1 [Срок оценки: Up to 30-37 Days after the last dose]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 16 центров

• 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
• … и ещё 8 центров

South Korea · 4 центра

• Clinical Trial Site — Busan
• Clinical Trial Site — Seongnam
• Clinical Trial Site — Seongnam
• Clinical Trial Site — Seoul

Италия · 3 центра

• Clinical Trial Site — Milan
• Clinical Trial Site — Rozzano
• Clinical Trial Site — Verona

Идентификаторы

NCT: NCT06600321 · ALN-BCAT-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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