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NCT07749703
PHASE1

A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors

Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

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