OncRef

Clinical Trial: NCT04276493

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:BeiGene
Information Provided By:BeOne Medicines
Last Update Posted:2026-09-02

Study Overview

Brief 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

Official Title

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

Conditions

Breast Cancer, Gastric Cancer, Gastroesophageal Junction Cancer

Intervention / Treatment

  • Biological: Zanidatamab
  • Drug: Docetaxel
  • Biological: Tislelizumab
  • Drug: Capecitabine
  • Drug: Oxaliplatin

Other Study ID Numbers

  • BGB-A317-ZW25-101
  • CTR20210237

Start Date (Actual)

2020-03-23

Primary Completion Date (Actual)

2023-12-07

Study Completion Date (Actual)

2024-10-31

Enrollment (Actual)

71

Study Type

Interventional

Phase

Phase 1, Phase 2