Clinical trial · Interventional
A Phase I Study of SIM0532 in Adult Participants With Advanced Solid Tumors
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
NCT07749703CI-TRIAL-00121508active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Histologically or Cytologically Confirmed Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SIM0532 Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Oral SIM0532
- interventionNames
- Drug: SIM0532 Tablets
Primary outcomes (4)
- measure
- Part 1: Dose-limiting toxicity (DLT)
- timeFrame
- Cycle 1 Day 1 (C1D1) to Cycle 1 Day 21 (C1D21) (Each cycle is 21 days)
- measure
- Part 1: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
- timeFrame
- From informed consent signing to 30 days after the last dose
- measure
- Part 2: Incidence and severity of subjects with AEs/SAEs
- timeFrame
- From informed consent signing to 30 days after the last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.