A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gastroesophageal Adenocarcinoma (GEA) - HERIZON-GEA-01

Zymeworks Inc.0 个研究点目标入组 1,149 人开始时间: 2021年8月10日最近更新: 2022年1月17日

试验速览

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•1.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 ISHpositivity per central assessment. Subjects with esophageal adenocarcinoma must not be eligible for combined chemoradiotherapy at the time of enrollment.
•2.Assessable (measurable or non-measurable) disease as defined by RECIST 1.1.
•3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, assessed within 3 days prior to randomization
•4.Adequate organ function
•5.Left ventricular ejection fraction (LVEF) = 50% as determined by either echocardiogram or multiple gated acquisition scan (MUGA)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 321
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 828

•1.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 GEA.
•2.Prior 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 pathways.
•3.Untreated 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 off steroids and anticonvulsants and are neurologically stable with no evidence of radiographic progression for at least 4 weeks prior to randomization).
•4.Known history of or ongoing leptomeningeal disease (LMD).
•5.Prior or concurrent invasive malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
•6.Known active hepatitis
•7.Any history of human immunodeficiency virus (HIV) infection
•8.Known SARS-CoV-2 infection; subjects with prior infection that has resolved per local institutions’ requirements and screening guidance are eligible
•9.Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF).
•10.QTc Fridericia (QTcF) > 470 ms.
•11.Ongoing Grade 2 or greater peripheral neuropathy

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