A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

Last updated: September 2, 2024
Sponsor: Chugai Pharmaceutical
Overall Status: Active - Not Recruiting

Phase

1

Condition

Carcinoma

Treatment

Tocilicumab

Bevacizumab

ERY974

Clinical Study ID

NCT05022927
ERY103JG
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 6months before enrollment.

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

  • Symptomatic, untreated, or actively progressing CNS metastases

Study Design

Total Participants: 179
Treatment Group(s): 4
Primary Treatment: Tocilicumab
Phase: 1
Study Start date:
June 01, 2021
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Chiba University Hospital

    Chiba-shi, Chiba 260-8677
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama, Kanagawa 241-8515
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Site Not Available

  • Chi Mei Medical Center

    Tainan, 71004
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 70142
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305
    Taiwan

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.