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Study of ISM3412 in Participants With Locally Advanced/Metastatic Solid Tumors
Sponsor: InSilico Medicine Hong Kong Limited
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
Conditions
Interventions
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