Hepatocellular Carcinoma (HCC)Phase 1NCT05022927
A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma
A Phase 1 study testing ERY974, Tocilicumab and Atezolizumab in people with Hepatocellular Carcinoma (HCC), run by Chugai Pharmaceutical at 11 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- ERY974, Tocilicumab and Atezolizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Jun 2021to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Taiwan6 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taichung Veterans General Hospital
Taichung, 40705
National Cheng Kung University Hospital
Tainan, 70142
Chi Mei Medical Center
Tainan, 71004
National Taiwan University Hospital
Taipei, 100
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
Japan5 sites
Chiba University Hospital
Chiba, Chiba, 260-8677
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
Kindai University Hospital
Sayama, Osaka, 589-8511
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
Official title: 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.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- ERY974, Tocilicumab, Atezolizumab, Bevacizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERY974Drug
ERY974 vial
TocilicumabDrug
Tocilizumab vial
AtezolizumabDrug
Atezolizumab vial
BevacizumabDrug
Bevacizumab vial
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation part | Experimental | 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. Receives: Drug: ERY974; Drug: Tocilicumab; Drug: Atezolizumab; Drug: Bevacizumab |
| Expansion part | Experimental | Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent To evaluate the anti-tumor effect. Receives: Drug: ERY974; Drug: Tocilicumab; Drug: Atezolizumab; Drug: Bevacizumab |
| Concomitant use part | Experimental | Patients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD. Receives: Drug: ERY974; Drug: Tocilicumab; Drug: Atezolizumab; Drug: Bevacizumab |
| Biomarker part | Experimental | Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent and to evaluate the biomarkers. Receives: Drug: ERY974; Drug: Tocilicumab; Drug: Atezolizumab; Drug: Bevacizumab |
| Mono dose escalation part | Experimental | 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. Receives: Drug: ERY974; Drug: Tocilicumab; Drug: Atezolizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Dose limiting toxicities) [Dose escalation part]
Incidence and nature of DLTs
Measured: 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]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
Measured: 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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
Measured: 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]
Heart Rate
Measured: 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]
Maximum plasma concentration (Cmax) of ERY974 Maximum plasma concentration (Cmax) of ERY974 Maximum plasma concentration (Cmax) of ERY974
Measured: 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 to reach maximum plasma drug concentration (Tmax) of ERY974
Measured: 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]
Area under the concentration versus time curve (AUC) of ERY974
Measured: 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]
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)
Measured: 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]
Incidence and nature of DLTs
Measured: 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]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
Measured: 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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
Measured: 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]
Heart Rate
Measured: 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]
Maximum plasma concentration (Cmax) of ERY974
Measured: 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 to reach maximum plasma drug concentration (Tmax) of ERY974
Measured: 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]
Area under the concentration versus time curve (AUC) of ERY974
Measured: 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]
GPC3 and PD-L1 IHC staining
Measured: From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Immune-related molecule IHC
Measured: From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Gene expression
Measured: From screening to 6weeks
Anti-tumor activity of ERY974 [Mono dose escalation part]
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)
Measured: 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]
Incidence and nature of DLTs
Measured: 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]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
Measured: 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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
Measured: 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]
Heart Rate
Measured: From first dose until 28 days after the last dose of study treatment, assessed up to about 52 weeks.
Secondary outcomes (20)
Anti-tumor activity of ERY974 in combination with atezolizumab and bevacizumab [Dose escalation part]
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)
Measured: From screening until disease progression, study discontinuation, withdrawal or death, whichever occurs first, assessed up to about 52 weeks.
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Adverse Events) [Expansion part]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
Measured: 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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
Measured: 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]
Heart Rate
Measured: 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]
Maximum plasma concentration (Cmax) of ERY974
Measured: 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 to reach maximum plasma drug concentration (Tmax) of ERY974
Measured: 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]
Area under the concentration versus time curve (AUC) of ERY974
Measured: 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]
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)
Measured: 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]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
Measured: 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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
Measured: 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.
Heart Rate
Measured: 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]
Maximum plasma concentration (Cmax) of ERY974
Measured: 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 to reach maximum plasma drug concentration (Tmax) of ERY974
Measured: 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 to reach maximum plasma drug concentration (AUC) of ERY974
Measured: 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]
Maximum plasma concentration (Cmax) of ERY974
Measured: 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 to reach maximum plasma drug concentration (Tmax) of ERY974
Measured: 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]
Area under the concentration versus time curve (AUC) of ERY974
Measured: 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]
GPC3 IHC staining
Measured: From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Immune-related molecule IHC
Measured: From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Gene expression
Measured: From screening to 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chugai Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sponsor Chugai Pharmaceutical Co. Ltd, Study director, clinical-trials@chugai-pharm.co.jp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022927
- Sponsor's protocol ID
- ERY103JG
- Status last verified
- Sep 2024
- First submitted
- 28 Jun 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 35853994
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE I STUDY OF ERY974 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
- ClinicalTrials.gov ID
- NCT05022927
- Acronym / sponsor ID
- ERY103JG
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 179 participants (estimated)
- Lead sponsor
- Chugai PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose escalation part | Experimental | Drug: ERY974, Drug: Tocilicumab, Drug: Atezolizumab, Drug: BevacizumabPatients 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. |
| Expansion part | Experimental | Drug: ERY974, Drug: Tocilicumab, Drug: Atezolizumab, Drug: BevacizumabPatients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent To evaluate the anti-tumor effect. |
| Concomitant use part | Experimental | Drug: ERY974, Drug: Tocilicumab, Drug: Atezolizumab, Drug: BevacizumabPatients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD. |
| Biomarker part | Experimental | Drug: ERY974, Drug: Tocilicumab, Drug: Atezolizumab, Drug: BevacizumabPatients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent and to evaluate the biomarkers. |
| Mono dose escalation part | Experimental | Drug: ERY974, Drug: Tocilicumab, Drug: Atezolizumab, Drug: BevacizumabPatients will receive ERY974 as a single agent and to determine the MTD by evaluating DLTs of in patients with locally advanced or metastatic HCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERY974ERY974 vial | Drug | Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part |
| TocilicumabTocilizumab vial | Drug | Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part |
| AtezolizumabAtezolizumab vial | Drug | Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part |
| BevacizumabBevacizumab vial | Drug | Biomarker part, Concomitant use part, Dose escalation part, Expansion part, Mono dose escalation part |
Primary outcome
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Time frame: From screening to 6weeks
GPC3 and PD-L1 IHC staining
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Time frame: From screening to 6weeks
Immune-related molecule IHC
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Time frame: From screening to 6weeks
Gene expression
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)
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
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
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
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
20 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Biomarkers of ERY974 [Mono dose escalation part]
Time frame: From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Time frame: From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Time frame: From screening to 6weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
- Derived from this study: PubMed 35853994Komatsu 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sponsor Chugai Pharmaceutical Co. Ltd study director
clinical-trials@chugai-pharm.co.jp
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ERY974, Tocilicumab and Atezolizumab in people with Hepatocellular Carcinoma (HCC), run by Chugai Pharmaceutical at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Taiwan, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05022927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.