A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

Sponsor
Chugai Pharmaceutical
Study ID
NCT05022927
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ERY974 — DRUG
    ERY974 vial
  • Tocilicumab — DRUG
    Tocilizumab vial
  • Atezolizumab — DRUG
    Atezolizumab vial
  • Bevacizumab — DRUG
    Bevacizumab vial

Study Details

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.

Key Dates

Start date
Jun 1, 2021
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
179 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation part
    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.
  • Experimental: Expansion part
    Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent To evaluate the anti-tumor effect.
  • Experimental: Concomitant use part
    Patients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD.
  • Experimental: Biomarker part
    Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent and to evaluate the biomarkers.
  • Experimental: Mono dose escalation part
    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.

Primary Outcome Measure

Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Dose limiting toxicities) [Dose escalation part] [ Time Frame: At the end of Cycle 2 (Cycle 1 is 14day, Cycle 2 or later is 21days) ]

Related Studies