Clinical Trial

Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

Recruiting Phase 1
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Summary
This is a Phase 1, 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 malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2024-08-19; most recent amendment 2026-02-12.
Status change: Not Yet Recruiting → Recruiting 2024-12-19
Trial Details
NCT Number NCT06566079
Lead Sponsor InSilico Medicine Hong Kong Limited
Conditions Malignant Mesothelioma, Metastatic Malignant Solid Tumor, Advanced Solid Tumor
Enrollment 100 participants
Start Date 2024-12-27
Primary Completion 2027-08-31 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-02-17