RecruitingPhase 1Phase 2NCT06414460

Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

A Phase 1/2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors

Sponsor

InSilico Medicine Hong Kong Limited

Enrollment

146 participants

Start Date

Apr 25, 2025

Study Type

INTERVENTIONAL

Conditions

Locally Advanced/Metastatic Solid Tumors

Summary

The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced/metastatic solid tumors, and to determine the RP2D of ISM3412.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called ISM3412 for people with locally advanced/metastatic solid tumors. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

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

DRUGISM3412

ISM3412 will be administered orally once daily.

Locations(10)

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, United States

Smilow Cancer Hospital at Yale New Haven Breast Center

New Haven, Connecticut, United States

Community Cancer Center North

Indianapolis, Indiana, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen university cancer center

Guangzhou, Guangdong, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Shanghai Gobroad Cancer Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06414460

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