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A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Summary
This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SHR-A1811 for injection in subjects with advanced non-small cell lung cancer who have HER2 expression , amplification, or mutation
Official title: Phase I/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A1811 for Injection in Subjects With Advanced Non-small Cell Lung Cancer Who Have HER2 Expression , Amplification, or Mutation
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
157
Start Date
2021-04-23
Completion Date
2025-06
Last Updated
2024-06-13
Healthy Volunteers
No
Conditions
Interventions
SHR-A1811
Phase 1 Drug: SHR-A1811 There are four pre-defined dose regimens . Subjects will be enrolled with an initial dose Phase 2 Drug: SHR-A1811 Doses will be determined from Phase 1
Locations (1)
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China