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

Primary Investigator
Crysler, Oxana
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06600321
UM Number
2024.111
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Gastrointestinal Oncology
ID (Protocol)
53456
Secondary Protocol No
HUM00261164
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Liver
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: 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