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Clinical Trials in China / NCT07749703
Active, not recruiting Phase 1

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

NCT07749703 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2026-03-31
Last updated
2026-08-11

Condition(s) studied

Histologically or Cytologically Confirmed Advanced Solid Tumors

Investigational drug(s) / intervention(s)

SIM0532 Tablets

SIM0532 Tablets: SIM0532 Tablets

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 1\. Signed the informed consent form prior to performing the specified procedures required by the study. * 2\. Aged ≥18 years. * 3\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * 4\. Expected survival ≥12 weeks. * 5\. Laboratory test results indicating sufficient organ function. * 6\. At least one measurable lesion per RECIST v1.1; Exclusion Criteria: * 1\. A history of other malignant tumors within 2 years. * 2\. With symptomatic central nervous system (CNS) metastases. * 3\. Gastrointestinal diseases that affect drug administration/absorption. * 4\. Known psychiatric disorders or substance abuse that may interfere with the conduct of the study. * 5\. Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage or medical intervention within 4 weeks. * 6\. Any active infection requiring systemic treatment within 2 weeks. * 7\. A history of non-infectious pneumonia requiring oral or intravenous steroid therapy for recovery, or interstitial lung disease (ILD) or severe obstructive pulmonary disease. * 8\. Previous treatment with RAS-targeting therapies other than RAS (OFF) inhibitors. * 9\. Failure to recover from adverse events (AEs) caused by previous antineoplastic therapy. * 10\. Currently participating in or having participated in a study of other investigational drugs or devices within 4 weeks. * 11\. Major surgery within 4 weeks. * 12\. Previous antineoplastic therapy before the first dose of study treatment should have a certain wash-out period * 13\. Vaccination with any live vaccine within 4 weeks. * 14\. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). * 15\. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; * 16\. A history of clinically significant cardiovascular disease. * 17\. A history of allogeneic organ transplantation or graft-versus-host disease (GVHD). * 18\. Known hypersensitivity to the study drug or any of its excipients. * 19\. Participants who are pregnant or breastfeeding.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
The First Affiliated Hospital of University of Science and Technology of China Hefei Anhui
The First Hospital of China Medical University Shenyang Liaoning
Shandong Cancer Hospital and Institute Jinan Shandong
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Jiangsu Simcere Pharmaceutical Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07749703 on ClinicalTrials.gov ↗ ← All trials in China