drugset / Trial / NCT07685704
Zanidatamab Combined With Chemotherapy as Neoadjuvant/Conversion Therapy for HER2-Positive (IHC 3+ or IHC 2+) Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: a Phase II Open-Label Study
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a phase II open-label study to evaluate the efficacy and safety of zanidatamab combined with chemotherapy as neoadjuvant/conversion therapy in patients with HER2-positive (IHC 3+ or IHC 2+) locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The study consists of two cohorts: a neoadjuvant cohort (Simon's two-stage design, n=46) for treatment-naive stage III locally advanced disease, and an exploratory conversion cohort for oligometastatic disease. Patients receive zanidatamab (30 mg/kg Q3W) plus oxaliplatin-based chemotherapy, with or without PD-1 inhibitor (tislelizumab or sintilimab). The primary endpoint is pathological complete response (pCR).
Timeline
- Start
- 2026-07
- Primary completion
- 2028-06
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | S-1 | Small molecule | 40 mg/m2 | Oral |
| Subject | Sintilimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Tislelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Zanidatamab | Monoclonal antibody | 30 mg/kg | — |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |