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Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
Sponsor: InSilico Medicine Hong Kong Limited
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-12-27
Completion Date
2028-02-28
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
ISM6331
Dosage form: Capsule for oral administration. Frequency of administration: Once daily overall of treatment.
Locations (10)
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Chicago, Illinois, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
University of Pennsylvania - Abramson Cancer Center
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
NEXT Oncology - Austin
Austin, Texas, United States
Henan Cancer Hospital
Zhengzhou, Henan, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Sun Yat-Sen University Cancer Center
Guangzhou, China