Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)

Phase 2 Not yet recruiting 70 enrolled Tao Zhang

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a prospective, multi-cohort clinical trial designed to evaluate the preliminary efficacy and safety of zanidatamab in combination with tislelizumab and chemotherapy/radiotherapy for patients with HER2-positive locally advanced or metastatic gastrointestinal tumors.

Timeline

Start: 2026-01-15
Primary completion: 2028-07-30
Completion: 2031-06-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Capecitabine	Small molecule	1000 mg/m2	Oral
Subject	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Subject	S-1	Small molecule	40 mg	Oral
Subject	S-1	Small molecule	50 mg	Oral
Subject	S-1	Small molecule	60 mg	Oral
Subject	Tisleizumab	Unknown	200 mg	Intravenous
Subject	Zanidatamab	Monoclonal antibody	1800 mg	Intravenous
Subject	Zanidatamab	Monoclonal antibody	2400 mg	Intravenous

Phase II Basket Trial: Zanidatamab Plus Tislelizumab in HER2-Positive GI Tumors (UNION-HER2-BASKET)

Summary

Timeline

Drugs

Indications