A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

NCT ID: NCT05022927

Last Updated: 2024-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

ERY974

Intervention Type DRUG

ERY974 vial

Tocilicumab

Intervention Type DRUG

Tocilizumab vial

Atezolizumab

Intervention Type DRUG

Atezolizumab vial

Bevacizumab

Intervention Type DRUG

Bevacizumab vial

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.

Group Type EXPERIMENTAL

ERY974

Intervention Type DRUG

ERY974 vial

Tocilicumab

Intervention Type DRUG

Tocilizumab vial

Atezolizumab

Intervention Type DRUG

Atezolizumab vial

Bevacizumab

Intervention Type DRUG

Bevacizumab vial

Concomitant use part

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

Group Type EXPERIMENTAL

ERY974

Intervention Type DRUG

ERY974 vial

Tocilicumab

Intervention Type DRUG

Tocilizumab vial

Atezolizumab

Intervention Type DRUG

Atezolizumab vial

Bevacizumab

Intervention Type DRUG

Bevacizumab vial

Biomarker part

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

Group Type EXPERIMENTAL

ERY974

Intervention Type DRUG

ERY974 vial

Tocilicumab

Intervention Type DRUG

Tocilizumab vial

Atezolizumab

Intervention Type DRUG

Atezolizumab vial

Bevacizumab

Intervention Type DRUG

Bevacizumab vial

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.

Group Type EXPERIMENTAL

ERY974

Intervention Type DRUG

ERY974 vial

Tocilicumab

Intervention Type DRUG

Tocilizumab vial

Atezolizumab

Intervention Type DRUG

Atezolizumab vial

Bevacizumab

Intervention Type DRUG

Bevacizumab vial

Interventions

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ERY974

ERY974 vial

Intervention Type DRUG

Tocilicumab

Tocilizumab vial

Intervention Type DRUG

Atezolizumab

Atezolizumab vial

Intervention Type DRUG

Bevacizumab

Bevacizumab vial

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sponsor Chugai Pharmaceutical Co. Ltd

Role: STUDY_DIRECTOR

[email protected]

Locations

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Chiba University Hospital

Chiba, Chiba, Japan

Site Status

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Site Status

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

Kindai University Hospital

Sayama, Osaka, Japan

Site Status

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Site Status

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Chi Mei Medical Center

Tainan City, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Linkou Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Site Status

Countries

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Japan Taiwan

References

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Komatsu SI, Kayukawa Y, Miyazaki Y, Kaneko A, Ikegami H, Ishiguro T, Nakamura M, Frings W, Ono N, Sakata K, Fujii T, Kishishita S, Kitazawa T, Endo M, Sano Y. Determination of starting dose of the T cell-redirecting bispecific antibody ERY974 targeting glypican-3 in first-in-human clinical trial. Sci Rep. 2022 Jul 19;12(1):12312. doi: 10.1038/s41598-022-16564-x.

Reference Type DERIVED
PMID: 35853994 (View on PubMed)

Other Identifiers

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ERY103JG

Identifier Type: -

Identifier Source: org_study_id

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