A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Aged ≥18 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hepatocellular Carcinoma (HCC)
Age (in years)
20+
Phase
Phase 1
Participants needed
158
Est. Completion Date
Sep 30, 2024
Treatment type
Interventional
Sponsor
Chugai Pharmaceutical
ClinicalTrials.gov identifier
NCT05022927
Study number
ERY103JG
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?