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RECRUITING
NCT05482568
PHASE1/PHASE2

A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This study was an open, multicenter, dose-increasing/investigational Phase IB/II clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.

Official title: Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2022-09-15

Completion Date

2026-12

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DRUG

SHR-A1811 & Pyrotinib/SHR-A1811 & SHR-1316

Drug: SHR-A1811 \& Pyrotinib SHR-A1811: intravenous Pyrotinib:oral Drug: SHR-A1811 \& SHR-1316 SHR-A1811: intravenous SHR-1316: intravenous

Locations (2)

Shanghai Chest hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China