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RECRUITING
NCT06414460
PHASE1

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

Sponsor: InSilico Medicine Hong Kong Limited

View on ClinicalTrials.gov

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.

Official title: A Phase 1, 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-04-25

Completion Date

2029-03-31

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DRUG

ISM3412

ISM3412 will be administered orally once daily.

Locations (9)

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

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