Clinical Trials /

A Study of ERY974 in Patient With Advanced Solid Tumors

NCT02748837

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
  • Gastric Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

A Study of ERY974 in Patient With Advanced Solid Tumors

Title

  • Brief Title: A Study of ERY974 in Patient With Advanced Solid Tumors
  • Official 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
  • Clinical Trial IDs

    NCT ID: NCT02748837

    ORG ID: ERY101EG

    Trial Conditions

    Solid Tumors

    Trial Interventions

    Drug Synonyms Arms
    ERY974 Dose escalation cohort of ERY974, Cohort expansion in gastric cancer, Cohort expansion in esophageal carcinoma, Cohort expansion in other solid tumors

    Trial Purpose

    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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Dose escalation cohort of ERY974 Experimental Dose escalation (DE) will proceed with the dose level increment and the dose cohort size being guided by a safety evaluations during and at the end of each cohort. DE initially utilizes an accelerated titration design (ATD) and once the first dose limiting toxicity (DLT) is observed, DE will continue using a modified continual reassessment method (mCRM) until MTD. ERY974
    Cohort expansion in gastric cancer Experimental Patients with GPC3 positive advanced gastric cancer or gastroesophageal junction cancer will receive ERY974 at recommended dose until disease progression. ERY974
    Cohort expansion in esophageal carcinoma Experimental Patients with GPC3 positive advanced squamous cell esophageal carcinoma will receive ERY974 at recommended dose until disease progression. ERY974
    Cohort expansion in other solid tumors Experimental Patients with other GPC3 positive advanced solid tumors will receive ERY974 at recommended dose until disease progression ERY974

    Eligibility Criteria

    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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Dose escalation MTD determination

    Cohort expansionPreliminary assessment of change in tumor size

    Secondary Outcome Measures

    Dose escalation Number and severity of adverse events

    Dose escalation Plasma ERY974 concentrations

    Dose escalationArea under curve (AUC)

    Dose escalationterminal half-life

    Dose escalationtotal clearance

    Dose escalationvolume distribution

    Dose escalation Change in tumor size assessed by mRECIST

    Dose escalation Determining the recommended dose

    Cohort expansionNumber and severity of adverse events

    Cohort expansion Plasma ERY974 concentrations

    Cohort expansion Area under curve (AUC)

    Cohort expansion terminal half-life

    Cohort expansion total clearance

    Cohort expansion volume distribution

    Trial Keywords