Clinical Trial 18739

Cancer Type: Gastrointestinal Tumor
Interventions:ERY974

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Mihaela Druta

Overview

Study Title

A Phase 1 Dose Escalation And Cohort Expansion Study Of ERY974, AN ANTI-GLYPICAN 3 (GPC3)/CD3 Bispecific Antibody, In Patients With Advanced Solid Tumors

Summary

The purpose of this study is to find the highest dose of ERY974 which can be safely given to participants with tumors and to find out what effects ERY974 has, good and bad.

Objective

DOSE ESCALATION PHASE: To determine the maximum tolerated dose (MTD) of ERY974 in patients with locally advanced or metastatic solid tumors expressing glypican 3 (GPC3). COHORT EXPANSION PHASE: To make a preliminary assessment of the anti-tumor activity of ERY974 in gastric/gastro-esophageal junction (GEJ), esophagus and other GPC3 positive tumors.

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