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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 16, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06566079). This is a study registration, not published results. Lead sponsor: InSilico Medicine Hong Kong Limited. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 160 participants (ESTIMATED). Conditions: Malignant Mesothelioma, Metastatic Malignant Solid Tumor, Advanced Solid Tumor. Interventions: DRUG: ISM6331. Primary outcome measures: Incidence of dose-limiting toxicity (DLT). , Day 1 up to Day 31; Incidence and severity of adverse events (AEs) , Approximately 12 months.; Incidence of clinically significant abnormalities in laboratory values, vital signs, physical examination, and electrocardiogram (ECG) measurements. , Approximately 12 months.; Recommended Phase 2 Dose (RP2D) , Approximately 40 months. Brief summary: This is a Phase 1/2, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic mesothelioma or other Advanced solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection expansion part (Part 2).