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.

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion

Interventions

Type	Name	Description
DRUG	SIM1803-1A	SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.

Timeline

• Start date: 2020-12-21
• Primary completion: 2022-09-30
• Completion: 2024-01-30
• First posted: 2020-12-17
• Last updated: 2021-01-13

Locations

1 site across 1 country: China