RecruitingPhase 1NCT06566079

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


Sponsor

InSilico Medicine Hong Kong Limited

Enrollment

100 participants

Start Date

Dec 27, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing ISM6331 — a new drug targeting the Hippo signaling pathway (a molecular pathway that controls cell growth) — in patients with advanced malignant mesothelioma (a rare cancer often linked to asbestos exposure) or other advanced solid tumors with specific genetic alterations in this pathway. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic malignant mesothelioma, or another solid tumor with documented Hippo pathway dysregulation - For mesothelioma: you have had prior treatment including immunotherapy and platinum-based chemotherapy - You have measurable disease on imaging - You are in good general health (ECOG ≤1) - Your blood, liver, and kidney function are adequate **You may NOT be eligible if...** - You have had certain prior therapies that conflict with study requirements - You are pregnant or breastfeeding - You have active serious infections or significant autoimmune disease - Your general health status is poor (ECOG above 1) - You have had recent major cardiac events Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGISM6331

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

View Full Details on ClinicalTrials.gov

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NCT06566079


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