drugset / Trial / NCT04671849

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.

NCT04671849 ↗

Phase 1 Unknown 243 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2020-12-21
Primary completion
2022-09-30
Completion
2024-01-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SIM1803-1A Unknown — Oral