A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label, dose-escalation study designed to determine the maximum tolerated dose (MTD) by evaluating dose-limiting toxicities (DLTs) and to evaluate the safety, tolerability, pharmacokinetics, anti-tumor effect, and biomarkers of ERY974 in combination with atezolizumab and bevacizumab following premedication with tocilizumab in patients with locally advanced or metastatic HCC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical
• Treatments: Atezolizumab; Bevacizumab

Criteria

Inclusion Criteria:

• Aged ≥20 years at time of informed consent

• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1

• HCC that has been histologically confirmed

Exclusion Criteria:

• Previous or concomitant autoimmune disease

• Uncontrolled diabetes mellitus and hypertension

• Concurrent New York Heart Association (NYHA) Class ≥II congestive heart failure, myocardial infarction, arrhythmia, or unstable angina, or a history thereof within 6 months before enrollment.

• Concurrent symptomatic cerebrovascular disorder (e.g., subarachnoid hemorrhage, cerebral infarction, or transient ischemic attack), or a history thereof within 6 months before enrollment.

• Symptomatic, untreated, or actively progressing CNS metastases