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

Running, not enrolling · Phase 1

Conditions studied: Histologically or Cytologically Confirmed Advanced Solid Tumors

In brief

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).

Key facts

Study ID

NCT07749703

Run by

Jiangsu Simcere Pharmaceutical Co., Ltd.

People needed

346

Starts

2026-03-31

Expected to finish

2030-06-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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