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An Open Label, Multi-center, Phase I Clinical Study to Evaluate the Safety, Effectiveness and Pharmacokinetic Characteristics of SIM1803-1A in Patients With Locally Advanced/Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion Mutations.
Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Summary
This research study is done to test the safety, effectiveness and pharmacokinetic characteristics of SIM1803-1A in patients with locally advanced/metastatic solid tumors with NTRK, ROS1 or ALK gene fusion mutations. The cancer must have a change in a particular gene (NTRK1, NTRK2, NTRK3, ROS1 or ALK). SIM1803-1A is a drug that blocks the actions of these NTRK/ ROS1 /ALK genes in cancer cells and can therefore be used to treat cancer.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2020-12-21
Completion Date
2023-03-16
Last Updated
2026-09-24
Healthy Volunteers
No
Interventions
SIM1803-1A
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.
Locations (1)
Shanghai Chest Hospital
Shanghai, China