Last updated 33 days ago
A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers
918 patients around the world
Available in Chile, Spain, Argentina
Zymeworks Inc.
38Research sites
918Patients around the world
This study is for people with
Esophageal cancer
Gastric cancer
Gastroesophageal cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically confirmed unresectable locally advanced, recurrent or metastatic HER2-positive gastroesophageal adenocarcinoma (adenocarcinomas of the stomach or esophagus, including the gastroesophageal junction), defined as 3+ HER2 expression by IHC or 2+ HER2 expression by IHC with ISH positivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollmentAssessable (measurable or non-measurable) disease as defined by RECIST 1.1Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomizationAdequate organ functionLeft ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)
- Prior treatment with a HER2-targeted agent, with the exception of subjects who received HER2-targeted treatment for breast cancer > 5 years prior to initial diagnosis of GEAPrior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathwaysPrior treatment with systemic antineoplastic therapy or intraperitoneal chemotherapy for unresectable locally advanced, recurrent or metastatic GEAUntreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks prior to randomization. Stable, treated brain metastases are allowed (defined as subjects who are completely off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization)Known history of or ongoing leptomeningeal disease (LMD)Known additional malignancy that is not considered cured or that has required treatment within the past 3 yearsKnown active hepatitisAny history of human immunodeficiency virus (HIV) infectionKnown SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions' requirements and screening guidance are eligibleQTc Fridericia (QTcF) > 470 msClinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF)
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Instituto Do Câncer Do Ceará ICC
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Recruiting
Instituto Do Câncer Do Ceará ICC
Recruiting
Corporacion de Beneficencia Osorno
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
StudyHERIZON-GEA-01
SponsorZymeworks Inc.
Study typeInterventional
Conditions
Esophageal cancerGastric cancerGastroesophageal cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05152147
