NCT04818333

A Study of SHR-A1811 in Subjects With Advanced Non-small Cell Lung Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 157 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	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

Timeline

• Start date: 2021-04-23
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2021-03-26
• Last updated: 2024-06-13

Locations

1 site across 1 country: China