A PHASE I STUDY OF ERY974 IN PATIENTS WITH HEPATOCELLULAR CARCINOMA

JRCT ID: jRCT2031200382

Registered date:01/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
• Date of first enrollment: 01/06/2021
• Target sample size: 179
• Countries of recruitment: Taiwan,Japan,Singapore,Japan,HongKong,Japan
• Study type: Interventional

Intervention(s)

ERY974: intravenous administration(IV), Prescribed dose
Tocilizumab: intravenous administration(IV), Prescribed dose
Atezolizumab: intravenous administration(IV), Prescribed dose
Bevacizumab: intravenous administration(IV), Prescribed dose

Outcome(s)

Primary Outcome

safety
NCI CTCAE

Secondary Outcome

efficacy
RECIST

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Wataya Takafumi
• Secondary ID(s): NCT05022927