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Clinical Trial 19883

Cancer Type: Gastrointestinal Tumor
Interventions:5-fluorouracil; Oxaliplatin; ZW25; eloxatin (Oxaliplatin); leucovorin

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Rutika Mehta

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 2 Study of ZW25 Plus First-line Combination Chemotherapy in HER2-Expressing Gastroesophageal Adenocarcinoma (GEA)

Summary

Objective

Objectives: - To characterize the safety and tolerability of ZW25 when administered with physician's choice of combination chemotherapy - To establish the RD of ZW25 when administered with physician's choice of first-line combination chemotherapy Secondary: - To evaluate anti-tumor activity of ZW25 when administered with physician's choice of combination chemotherapy in patients receiving first-line treatment for HER2-expressing GEA (IHC 3+ or 2+ with or without gene amplification based upon local assessment) - To characterize the immunogenicity of ZW25 when administered in combination with physician's choice of first-line combination chemotherapy - To evaluate the PK of ZW25 when administered in combination with physician's choice of first-line combination chemotherapy

Inclusion Criteria

  • Disease diagnosis:
  • Part 1: Unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA (IHC 3+ or 2+ with or without gene amplification based upon local assessment)
  • Part 2: Unresectable, locally advanced, recurrent or metastatic HER2-high GEA (IHC 3+, or IHC 2+ and FISH+ by central review)
  • Tumor measurements as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1:
  • Part 1: Measurable or non-measurable disease
  • Part 2: Measurable disease
  • ECOG performance status score of 0 or 1
  • Adequate organ function
  • Adequate cardiac left ventricular function, as defined by a LVEF >/= institutional standard of normal

  • Exclusion Criteria

  • Prior treatment with a HER2-targeted agent
  • Treatment with prior anti-cancer therapy, except prior adjuvant/neoadjuvant therapy, which must be completed at least 6 months prior to study treatment dosing
  • Untreated known brain metastases (patients with treated brain metastases who are off steroids and are stable for at least 1 month at the time of screening are eligible)
  • Having clinically significant cardiac disease or known myocardial infarction or unstable angina (within 6 months before first study treatment dosing)
  • QTc Fridericia (QTcF) > 450 ms
  • Peripheral neuropathy > Grade 1 per NCI-CTCAE v5.0
  • Clinically significant interstitial lung disease
  • Known active hepatitis B or C (per the Centers for Disease Control guidelines) or known infection with human immunodeficiency virus (HIV)