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Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Start Date
March 30, 2021
Primary Completion Date
March 28, 2025
Completion Date
March 28, 2025
Last Updated
February 6, 2026
101
ACTUAL participants
SHR-A1811
DRUG
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
NCT06696768
NCT04704661
Data Source & Attribution
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