A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

Chugai Pharmaceutical

Status and phase: Active, not recruiting; Phase 1

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Drug: Atezolizumab; Drug: Tocilicumab; Drug: ERY974; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05022927

ERY103JG

Details and patient eligibility

About

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.

Enrollment: 179 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

179 participants in 5 patient groups

Dose escalation part

Experimental group

Description:

Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent and to determine the MTD by evaluating DLTs of in patients with locally advanced or metastatic HCC.

Treatment:

Drug: Bevacizumab

Drug: ERY974

Drug: Tocilicumab

Drug: Atezolizumab

Expansion part

Experimental group

Description:

Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent To evaluate the anti-tumor effect.

Treatment:

Drug: Bevacizumab

Drug: ERY974

Drug: Tocilicumab

Drug: Atezolizumab

Concomitant use part

Experimental group

Description:

Patients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD.

Treatment:

Drug: Bevacizumab

Drug: ERY974

Drug: Tocilicumab

Drug: Atezolizumab

Biomarker part

Experimental group

Description:

Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent and to evaluate the biomarkers.

Treatment:

Drug: Bevacizumab

Drug: ERY974

Drug: Tocilicumab

Drug: Atezolizumab

Mono dose escalation part

Experimental group

Description:

Patients will receive ERY974 as a single agent and to determine the MTD by evaluating DLTs of in patients with locally advanced or metastatic HCC.

Treatment:

Drug: Bevacizumab

Drug: ERY974

Drug: Tocilicumab

Drug: Atezolizumab