Clinical trial details

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)

Identifier

ZWI-ZW25-301

Sponsor

ZYMEWORKS INC.

Principal Investigator

JOSEP TABERNERO CATURLA

Service

Oncology

Study details

Tumor type: GASTROESOPHAGEAL
Stage: Advanced
Main Investigational Agent : Targeted therapy
Phase: III
Randomization: Randomized

Molecular details

Biomarker: HER2 pos
Biomarker criteria: Mandatory
Prescreening: Central
Additional study population 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 enrollment

Drug details

Arm A: Trastuzumab (Herceptin®) plus physicians choice of capecitabine plus oxaliplatin (CAPOX) or 5-fluorouracil (5-FU) plus cisplatin (FP)
Arm B: Zanidatamab and tislelizumab plus physicians choice of CAPOX or FP
Arm C: Zanidatamab plus physicians choice of CAPOX or FP

Links

Clinical Trials GOV (NCT identifier): NCT05152147
EU Clinical Trials Register (eudraCT Identifier): 2021-000296-36