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A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
an open-label, multicenter, Phase I study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of SIM0532 in participants with advanced solid tumors. The study commences with a dose-escalation part (Part 1), followed by a dose-expansion part (Part 2).
Official title: An Open-label, Multicenter, First-in-human Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SIM0532 in Adult Participants With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
346
Start Date
2026-03-31
Completion Date
2030-06-30
Last Updated
2026-08-11
Healthy Volunteers
No
Interventions
SIM0532 Tablets
SIM0532 Tablets
Locations (6)
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital and Institute
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China