Call us 24/7

A safety and efficacy study of ZW25 plus combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (ZWI-ZW25-201)

Description

This is a multicenter, global, Phase 2, open-label, 2-part, first-line study to investigate the safety, tolerability, and anti-tumor activity of ZW25 plus physician's choice of combination chemotherapy in HER2-expressing gastroesophageal adenocarcinoma (GEA). Eligible patients include those with unresectable, locally advanced, recurrent or metastatic HER2-expressing GEA.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective for Part 1 is the incidence of dose-limiting toxicities (DLTs). The primary objective for Part 2 is the objective response rate (ORR).

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet the following 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 or central 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

Excluding patients who meet the following 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 first study treatment dosing; and/or treatment with other cancer therapy, not otherwise specified in the exclusion criteria, within 4 weeks before the first dose of ZW25
  • 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
  • Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Active hepatitis B or hepatitis C infection or other known chronic liver disease or infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2 (Exception: patients with well controlled HIV [e.g., CD4>350/mm3 and undetectable viral load] are eligible.)
     

Accepting new patients

 

Learn more at

clinicaltrials.gov