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Completed

NCT Number: NCT02748837

A Study of ERY974 in Patient With Advanced Solid Tumors

This is the open label, multicenter Phase 1 study which consists of a dose escalation to determine the maximum tolerated dose (MTD) and cohort expansion to obtain a preliminary evaluation of anti-tumor activity. ERY974 is intravenously injected to patients with Glypican 3 positive advanced solid tumors until unacceptable toxicity or disease progression.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paris, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patient with Glypican 3 positive advanced solid tumor not amenable to standard therapy or for which standard therapy is not available or not indicated
  • Measurable tumor
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Adequate bone marrow, liver, and renal function
  • Adequate coagulation status

Exclusion criteria

  • Patients with more than a single brain metastasis ( >1 cm)
  • Patients with acute or chronic infection
  • Major surgery within 28 days
  • Pregnant or lactating women
  • Patients with interstitial pneumonitis
  • Patients require regular ascites/pleural effusion drainage

Treatment and study plan

ERY974

Drug

Primary outcomes

  1. Dose escalation： MTD determination

    Time frame: DLT evaluation period, defined as from the first ERY974 injection until 7 days after the third injection

    Determination of dose-limiting toxicities (DLT)

  2. Cohort expansion：Preliminary assessment of change in tumor size

    Time frame: From the date of informed consents obtained until disease progression: at screening , week 6,12,18 and subsequently every 3 months up to 38 months

    Anti-tumor activity will be assessed by modified Response Evaluation Criteria in Solid Tumors (mRECIST)

Secondary outcomes

  1. Dose escalation： Number and severity of adverse events

    Time frame: Adverse events will be reported through 28 days after the last dose

  2. Dose escalation： Plasma ERY974 concentrations

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  3. Dose escalation：Area under curve (AUC)

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  4. Dose escalation：terminal half-life

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  5. Dose escalation：total clearance

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  6. Dose escalation：volume distribution

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  7. Dose escalation： Change in tumor size assessed by mRECIST

    Time frame: From the date of informed consents obtained until disease progression: at screening , week 6,12,18 and subsequently every 3 months up to 38 months

  8. Dose escalation： Determining the recommended dose

    Time frame: Recommended dose will be determined after completion of DLT assessments in all dose escalation cohorts. It is estimated as 18 months after first patient enrollment.

  9. Cohort expansion：Number and severity of adverse events

    Time frame: Adverse events will be reported through 28 days after the last dose

  10. Cohort expansion ：Plasma ERY974 concentrations

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  11. Cohort expansion ：Area under curve (AUC)

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  12. Cohort expansion ：terminal half-life

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  13. Cohort expansion ：total clearance

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

  14. Cohort expansion ：volume distribution

    Time frame: PK will be assessed from day 1 to day 22, day 1 to day 29, or day 1 to day 36, then every 3 weeks from day 43 until end of treatment visit, up to 38 months

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study title

A Phase 1 Dose Escalation and Cohort Expansion Study of ERY974, An Anti-Glypican3 (GPC3)/CD3 Bispecific Antibody, in Patients With Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2016
Registry last updated
Aug 22, 2019

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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