NCT07243938

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

A Prospective, Multi-cohort Clinical Study to Explore the Preliminary Efficacy and Safety of Zanidatamab in Combination With Tislelizumab for HER2-Positive GI Tumors: the UNION-HER2-BASKET Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Tao Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, multi-cohort clinical trial designed to explore the preliminary efficacy and safety of zanidatamab combined with tislelizumab and chemoradiotherapy in patients with HER2-positive locally advanced or metastatic gastrointestinal tumors. The study comprises three cohorts: ①Locally Advanced Rectal Cancer Cohort: Evaluate the preliminary efficacy of zanidatamab combined with tislelizumab and chemoradiotherapy for neoadjuvant and organ-preserving therapy in patients with HER2-positive locally advanced rectal cancer, as measured by investigator-assessed complete response rate (CR rate).②Locally Advanced Gastric/Gastroesophageal Junction Cancer Cohort:Evaluate the preliminary efficacy of zanidatamab combined with tislelizumab and chemotherapy for neoadjuvant treatment in patients with HER2-positive locally advanced gastric/gastroesophageal junction cancer based on investigator-assessed pathological complete response rate (pCR rate).③Advanced-line colorectal cancer cohort: Evaluate the preliminary efficacy of zanidatamab combined with tislelizumab in patients with HER2-positive advanced-line colorectal cancer based on investigator-assessed progression-free survival (PFS).

Conditions

• Locally Advanced Rectal Cancer (LARC)
• Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
• Metastatic Colorectal Cancer (mCRC)
• Neoadjuvant Therapy

Interventions

Type	Name	Description
RADIATION	short-course radiotherapy	25Gy, 5Gy×5
DRUG	Zanidatamab	1800mg(\<70kg)/2400mg(≥70kg), IV，D1，Q3W
DRUG	Tisleizumab(BGB-A317)	200 mg，IV，D1，Q3W
DRUG	Capecitabine	1000mg/m2/time，BID，PO，D1-14, Q3W
DRUG	Oxaliplatin	130 mg/m2/次，IV，D1, Q3W
PROCEDURE	TME surgery	The surgery was performed 4 - 6 weeks after the end of neoadjuvant therapy in patients who assessed as non-cCR.
DRUG	S-1	40\~60mg bid，po, d1\~14，Q3W （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid）
PROCEDURE	D2	Radical gastrectomy with D2 lymph node dissection was performed within 4-6 weeks after the completion of neoadjuvant therapy in patients without tumor progression on preoperative imaging assessment.

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-07-30
• Completion: 2031-06-01
• First posted: 2025-11-24
• Last updated: 2025-11-24