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RECRUITING
NCT06566079
PHASE1

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

Sponsor: InSilico Medicine Hong Kong Limited

View on ClinicalTrials.gov

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

DRUG

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