NCT06566079

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

A Phase 1, Open-Label, Multicenter, FIH Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: InSilico Medicine Hong Kong Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Malignant Mesothelioma
• Metastatic Malignant Solid Tumor
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	ISM6331	Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.

Timeline

• Start date: 2024-12-27
• Primary completion: 2027-08-31
• Completion: 2028-02-28
• First posted: 2024-08-22
• Last updated: 2026-02-17

Locations

10 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study