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NCT Number: NCT05022927

A Phase I Study of ERY974 in Patients With 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chiba University Hospital, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERY974

Drug

ERY974 vial

Tocilicumab

Drug

Tocilizumab vial

Atezolizumab

Drug

Atezolizumab vial

Bevacizumab

Drug

Bevacizumab vial

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]

    Time frame: From screening to 6weeks

    GPC3 and PD-L1 IHC staining

  17. Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]

    Time frame: From screening to 6weeks

    Immune-related molecule IHC

  18. Biomarkers of ERY974 in combination with atezolizumab and bevacizumab [Biomarker part]

    Time frame: From screening to 6weeks

    Gene expression

  19. 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)

  20. 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

  21. 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

  22. 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

  23. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Biomarkers of ERY974 [Mono dose escalation part]

    Time frame: From screening to 6weeks

    GPC3 IHC staining

  19. Biomarkers of ERY974 [Mono dose escalation part]

    Time frame: From screening to 6weeks

    Immune-related molecule IHC

  20. Biomarkers of ERY974 [Mono dose escalation part]

    Time frame: From screening to 6weeks

    Gene expression

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2021
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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