NCT04276493

Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab

Phase 1b/2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-HER2 Bispecific Antibody ZW25 in Combination With Chemotherapy With/Without Tislelizumab in Patients With Advanced HER2-positive Breast Cancer or Gastric/Gastroesophageal Junction Adenocarcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety, tolerability and preliminary antitumor activity of zanidatamab in combination with docetaxel in participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and zanidatamab in combination with tislelizumab and chemotherapy in participants with HER2-positive gastric/gastroesophageal Junction (GEJ) adenocarcinoma

Conditions

• Breast Cancer
• Gastric Cancer
• Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Zanidatamab	Administered intravenously
DRUG	Docetaxel	Administered intravenously
BIOLOGICAL	Tislelizumab	Administered intravenously
DRUG	Capecitabine	Administered orally
DRUG	Oxaliplatin	Administered intravenously

Timeline

• Start date: 2020-03-26
• Primary completion: 2023-12-07
• Completion: 2024-10-31
• First posted: 2020-02-19
• Last updated: 2024-12-06

Locations

21 sites across 3 countries: China, South Korea, Taiwan

Regulatory

• FDA-regulated drug study