A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma
NCT ID: NCT05022927
Last Updated: 2024-09-05
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE1
179 participants
INTERVENTIONAL
2021-06-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
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.
ERY974
ERY974 vial
Tocilicumab
Tocilizumab vial
Atezolizumab
Atezolizumab vial
Bevacizumab
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.
ERY974
ERY974 vial
Tocilicumab
Tocilizumab vial
Atezolizumab
Atezolizumab vial
Bevacizumab
Bevacizumab vial
Concomitant use part
Patients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD.
ERY974
ERY974 vial
Tocilicumab
Tocilizumab vial
Atezolizumab
Atezolizumab vial
Bevacizumab
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.
ERY974
ERY974 vial
Tocilicumab
Tocilizumab vial
Atezolizumab
Atezolizumab vial
Bevacizumab
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.
ERY974
ERY974 vial
Tocilicumab
Tocilizumab vial
Atezolizumab
Atezolizumab vial
Bevacizumab
Bevacizumab vial
Interventions
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ERY974
ERY974 vial
Tocilicumab
Tocilizumab vial
Atezolizumab
Atezolizumab vial
Bevacizumab
Bevacizumab vial
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
* HCC that has been histologically confirmed
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Chiba University Hospital
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Kindai University Hospital
Sayama, Osaka, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chi Mei Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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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.
Other Identifiers
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ERY103JG
Identifier Type: -
Identifier Source: org_study_id
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