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)
Part 1: Dose-limiting toxicity (DLT) — Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)
Part 1: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) — From informed consent signing to 30 days after the last dose
Part 2: Incidence and severity of subjects with AEs/SAEs — From informed consent signing to 30 days after the last dose
Part 2: Objective response rate (ORR) — About 24 months.
Trial sites (6)
Facility
City
Region
Status
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
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.
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