A Phase 1 interventional study of ERY974 and Tocilicumab in Hepatocellular Carcinoma (HCC), sponsored by Chugai Pharmaceutical. Active, not recruiting at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Chugai Pharmaceutical · Phase 1, Interventional, and Treatment
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 179 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Chugai Pharmaceutical is the lead sponsor of 63 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Tocilicumab · Drug: Atezolizumab · Drug: Bevacizumab
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 · Drug: Tocilicumab · Drug: Atezolizumab · Drug: Bevacizumab
Patients will receive ERY974 in combination with atezolizumab and bevacizumab and to determine the MTD.
Drug: ERY974 · Drug: Tocilicumab · Drug: Atezolizumab · Drug: Bevacizumab
Patients will receive ERY974 in combination with atezolizumab and bevacizumab after administering ERY974 as a single agent and to evaluate the biomarkers.
Drug: ERY974 · Drug: Tocilicumab · Drug: Atezolizumab · Drug: Bevacizumab
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 · Drug: Tocilicumab · Drug: Atezolizumab · Drug: Bevacizumab
ERY974 vial
Tocilizumab vial
Atezolizumab vial
Bevacizumab vial
Safety and tolerability of ERY974 in combination with atezolizumab and bevacizumab (Dose limiting toxicities) [Dose escalation part]
Incidence and nature of DLTs
Time frame: 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
Time frame: 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
Time frame: 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
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 [Dose escalation part]
Maximum plasma concentration (Cmax) of ERY974 Maximum plasma concentration (Cmax) of ERY974 Maximum plasma concentration (Cmax) of ERY974
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 [Dose escalation part]
Time to reach maximum plasma drug concentration (Tmax) of ERY974
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 [Dose escalation part]
Area under the concentration versus time curve (AUC) of ERY974
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 [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)
Time frame: 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
Time frame: 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
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 from initiation [Concomitant use part]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
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 from initiation [Concomitant use part]
Heart Rate
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 from initiation [Concomitant use part]
Maximum plasma concentration (Cmax) of ERY974
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 from initiation [Concomitant use part]
Time to reach maximum plasma drug concentration (Tmax) of ERY974
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 from initiation [Concomitant use part]
Area under the concentration versus time curve (AUC) of ERY974
Time frame: 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
Time frame: From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Immune-related molecule IHC
Time frame: From screening to 6weeks
Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]
Gene expression
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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 [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)
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]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
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]
Heart Rate
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]
Maximum plasma concentration (Cmax) of ERY974
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 to reach maximum plasma drug concentration (Tmax) of ERY974
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]
Area under the concentration versus time curve (AUC) of ERY974
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]
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)
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]
Incidence, nature, and severity of adverse events (AEs) as assessed by the NCI CTCAE v5.0
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]
Uncorrected QT interval, QTcF, PR duration, QRS interval and RR interval
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.
Heart Rate
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]
Maximum plasma concentration (Cmax) of ERY974
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 to reach maximum plasma drug concentration (Tmax) of ERY974
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 to reach maximum plasma drug concentration (AUC) of ERY974
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]
Maximum plasma concentration (Cmax) of ERY974
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 to reach maximum plasma drug concentration (Tmax) of ERY974
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]
Area under the concentration versus time curve (AUC) of ERY974
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]
GPC3 IHC staining
Time frame: From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Immune-related molecule IHC
Time frame: From screening to 6weeks
Biomarkers of ERY974 [Mono dose escalation part]
Gene expression
Time frame: From screening to 6weeks
Plan to share: 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).
This study is active, not recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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