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.

PHASE1UnknownINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

December 21, 2020

Primary Completion Date

September 30, 2022

Study Completion Date

January 30, 2024

Conditions
Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
Interventions
DRUG

SIM1803-1A

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

Trial Locations (1)

Unknown

RECRUITING

Shanghai Chest Hospital, Shanghai

All Listed Sponsors
lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY