Clinical trial
A PHASE I STUDY OF ERY974 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Name
ERY103JG
Description
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.
Trial arms
Trial start
2021-06-01
Estimated PCD
2025-12-31
Trial end
2025-12-31
Status
Recruiting
Phase
Early phase I
Treatment
ERY974
ERY974 vial
Arms:
Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part
Tocilicumab
Tocilizumab vial
Arms:
Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part
Atezolizumab
Atezolizumab vial
Arms:
Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part
Bevacizumab
Bevacizumab vial
Arms:
Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part
Size
179
Primary endpoint
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Dose limiting toxicities) [Dose escalation part]
At the end of Cycle 2 (Cycle 1 is 14day, Cycle 2 or later is 21days)
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Electrocardiograms in triplicate) [Dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Electrocardiograms in triplicate) [Dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Electrocardiograms in triplicate) [Dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab [Dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab [Dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab [Dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Anti-tumor activity of ERY974 in combination with atezolizumab and bevacizumab [Expansion part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab from initiation (Dose limiting toxicities) [Concomitant use part]
At the end of Cycle 1 (each Cycle is 21days)
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Expansion part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab from initiation [Concomitant use part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab from initiation [Concomitant use part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab from initiation [Concomitant use part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab from initiation [Concomitant use part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab from initiation [Concomitant use part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
From screening to 6weeks
Anti-tumor activity of ERY974 [Mono dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety of ERY974 (Dose limiting toxicities) [Mono dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety of ERY974 (Dose limiting toxicities) [Mono dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety of ERY974 (Dose limiting toxicities) [Mono dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety of ERY974 (Dose limiting toxicities) [Mono dose escalation part]
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 179, 'type': 'ESTIMATED'}}
Updated at
2024-02-12
1 organization
4 products
1 indication
Organization
Chugai PharmaceuticalProduct
AtezolizumabIndication
Hepatocellular CarcinomaProduct
ERY974Product
TocilicumabProduct
Bevacizumab