Phase 1/2 Study of HS-10376 in Patients With Non-Small Cell Lung Cancer

Advanced Non-Small-Cell Lung Cancer Clinical Trial

Official title: A Phase 1/2, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10376 Monotherapy in Patients With Advanced Non-small-Cell Lung Cancer

Status Recruiting

Clinical Trial Summary

HS-10376 is an oral, highly selective, small molecular inhibitor of EGFR/HER2 Exon 20 insertion mutation. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10376 in Chinese advanced Non-Small Cell Lung Cancer (NSCLC) patients.

Clinical Trial Description

This is a phase 1/2, first-in-human, open-label, multicenter study of HS-10376, this study has two parts: phase 1 and phase 2. The phase 1 portion consists of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10376 in subjects with advanced NSCLC and evaluate the preliminary efficacy of HS-10376. Phase 2 will be conducted to evaluate the efficacy of HS-10376 in subjects with locally advanced or metastatic NSCLC with a EGFR Exon 20 insertion mutation. ;

Related Conditions & MeSH terms

• Advanced Non-Small-Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

• NCT number: NCT05435274
• Study type: Interventional
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: Dingzhi Huang
• Phone: 18622221232
• Email: dingzhi72@163.com
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 30, 2021
• Completion date: October 7, 2025