A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma

September 2, 2024 updated by: Chugai Pharmaceutical

A PHASE I STUDY OF ERY974 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
179

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Chiba
      • Chiba-shi, Chiba, Japan, 260-8677
        • Chiba University Hospital
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 71004
        • Chi Mei Medical Center
      • Tainan, Taiwan, 70142
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 33305
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: ERY974
ERY974 vial
Drug: Tocilicumab
Tocilizumab vial
Drug: Atezolizumab
Atezolizumab vial
Drug: Bevacizumab
Bevacizumab vial
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.
Drug: ERY974
ERY974 vial
Drug: Tocilicumab
Tocilizumab vial
Drug: Atezolizumab
Atezolizumab vial
Drug: Bevacizumab
Bevacizumab vial
Experimental: Concomitant use part
Patients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD.
Drug: ERY974
ERY974 vial
Drug: Tocilicumab
Tocilizumab vial
Drug: Atezolizumab
Atezolizumab vial
Drug: Bevacizumab
Bevacizumab vial
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.
Drug: ERY974
ERY974 vial
Drug: Tocilicumab
Tocilizumab vial
Drug: Atezolizumab
Atezolizumab vial
Drug: Bevacizumab
Bevacizumab vial
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.
Drug: ERY974
ERY974 vial
Drug: Tocilicumab
Tocilizumab vial
Drug: Atezolizumab
Atezolizumab vial
Drug: Bevacizumab
Bevacizumab vial

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Incidence and nature of DLTs
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Heart Rate
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Maximum plasma concentration (Cmax) of ERY974 Maximum plasma concentration (Cmax) of ERY974 Maximum plasma concentration (Cmax) of ERY974
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time to reach maximum plasma drug concentration (Tmax) of ERY974
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Area under the concentration versus time curve (AUC) of ERY974
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Objective Response Rate (ORR) is defined as proportion of patients who had a confirmed complete response (CR) or partial response (PR), as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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]
Time Frame: At the end of Cycle 1 (each Cycle is 21days)
Incidence and nature of DLTs
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Heart Rate
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Maximum plasma concentration (Cmax) of ERY974
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time to reach maximum plasma drug concentration (Tmax) of ERY974
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Area under the concentration versus time curve (AUC) of ERY974
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]
Time Frame: From screening to 6weeks
GPC3 and PD-L1 IHC staining
From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Time Frame: From screening to 6weeks
Immune-related molecule IHC
From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Time Frame: From screening to 6weeks
Gene expression
From screening to 6weeks
Anti-tumor activity of ERY974 [Mono dose escalation part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Objective Response Rate (ORR) is defined as proportion of patients who had a confirmed complete response (CR) or partial response (PR), as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Incidence and nature of DLTs
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
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]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Heart Rate
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
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 [Dose escalation part]
Time Frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to about 52 weeks.
Objective Response Rate (ORR) is defined as proportion of patients who had a confirmed complete response (CR) or partial response (PR), as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to about 52 weeks.
Safety, tolerability and pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety, tolerability and pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Heart Rate
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 [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Maximum plasma concentration (Cmax) of ERY974
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 [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time to reach maximum plasma drug concentration (Tmax) of ERY974
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 [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Area under the concentration versus time curve (AUC) of ERY974
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 from initiation [Concomitant use part]
Time Frame: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to about 52 weeks.
Objective Response Rate (ORR) is defined as proportion of patients who had a confirmed complete response (CR) or partial response (PR), as determined by the investigator with use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to about 52 weeks.
Safety of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Expansion part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Safety, tolerability and pharmacokinetics of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Biomarker part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Heart Rate
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 [Biomarker part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Maximum plasma concentration (Cmax) of ERY974
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 [Biomarker part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time to reach maximum plasma drug concentration (Tmax) of ERY974
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 [Biomarker part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time to reach maximum plasma drug concentration (AUC) of ERY974
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 [Mono dose escalation part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Maximum plasma concentration (Cmax) of ERY974
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 [Mono dose escalation part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Time to reach maximum plasma drug concentration (Tmax) of ERY974
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Pharmacokinetics of ERY974 [Mono dose escalation part]
Time Frame: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Area under the concentration versus time curve (AUC) of ERY974
From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Biomarkers of ERY974 [Mono dose escalation part]
Time Frame: From screening to 6weeks
GPC3 IHC staining
From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Time Frame: From screening to 6weeks
Immune-related molecule IHC
From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Time Frame: From screening to 6weeks
Gene expression
From screening to 6weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chugai Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sponsor Chugai Pharmaceutical Co. Ltd, clinical-trials@chugai-pharm.co.jp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ERY103JG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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