A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

Summary

This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.

Timeline

Start

2021-03-30

Primary completion

2025-03-28

Completion

2025-03-28

Publications

• Liu T, Luo S, Yuan X, Liu D, Zhou Z, Wang X, Deng Y, Chen J, Liu M, Zhou H, Ren X, Qiu W, Cao Y, Cai S, Dong Y, Zhang Y, Wang W, Liang J, Xu P, Liu H, Zhao K, Fan Y, Dou N, Huang C, Li J. Trastuzumab Rezetecan in Human Epidermal Growth Factor Receptor 2-Expressing Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: A Multicenter, Open-Label, Phase I Trial. J Clin Oncol. 2026 May;44(13):1225-1237. doi: 10.1200/JCO-25-00716. Epub 2026 Mar 4.

Drugs

Indications