A Study of ERY974 in Patient With Advanced Solid Tumors

Chugai Pharmaceutical29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

ERY974DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Washington D.C., District of Columbia, United States

Unnamed facility

Tampa, Florida, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Dose escalation： MTD determination

Determination of dose-limiting toxicities (DLT)

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

Cohort expansion：Preliminary assessment of change in tumor size

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

Secondary Outcomes

Dose escalation： Number and severity of adverse events

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

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

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

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

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

Data from ClinicalTrials.gov

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