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ACTIVE NOT RECRUITING
NCT05114759
PHASE1

A Phase I Clinical Study of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is an open-label, multicenter Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in patients with advanced solid tumors.

Official title: A Phase I, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A2009 for Injection in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

176

Start Date

2022-01-04

Completion Date

2026-12-30

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

DRUG

SHR-A2009

In dose Escalation: SHR-A2009 will be administered intravenously. Six dose levels are preset. In dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage. In indication Expansion: Indications will be selected to evaluate preliminary efficacy.

Locations (16)

Chongqing Cancer Hospital

Chongqicun, Chongqi, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of JiLin University

Changchun, Jlin, China

Shandong Cancer Hospital&Institute

Jinan, Shandong, China

The Second Affiliated Hospital of Air Force Military University Tangdu Hospital

Xi’an, Shanxi, China

Sichuan Cancer Hospital & Institute

Chengdu, Sichuan, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

National Cancer Center Hospital East

Chiba, Chiba, Japan

National Cancer Center Hospital

Tokyo, Tokyo, Japan

Seoul National University Hospital

Seoul, Seoul, South Korea

Asan Medical Center

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea