A Phase 1 interventional study of SIM1803-1A in Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
Jiangsu Simcere Pharmaceutical Co., Ltd. is the lead sponsor of 75 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: SIM1803-1A
Drug: SIM1803-1A
Drug: SIM1803-1A
Drug: SIM1803-1A
Drug: SIM1803-1A
Drug: SIM1803-1A
Drug: SIM1803-1A
Drug: SIM1803-1A
SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.
Number of participants with adverse events
Number of participants with adverse events
Time frame: 5 years
Severity of adverse events
Severity of adverse events
Time frame: 5 years
Maximum tolerated dose
Maximum tolerated dose
Time frame: 5 years
Recommended dose for dose expansion
Recommended dose for dose expansion
Time frame: 5 years
Maximum concentration of SIM1803-1A in plasma (Cmax)
Maximum concentration of SIM1803-1A in plasma (Cmax)
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days）
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted)
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)\_fasted)
Time frame: Up to 1 day
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC\_fasted)
Time frame: Up to 3 days
Number of participants with treatment-emergent adverse events (TEAEs)
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 24 weeks
Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Time frame: Predose and 0.25, 0.5, 1, 2, 4, 8，12，24and 48 hours after drug administration on Days 1 and 8 of Cycle 1（each cycle is 21 days)
Overall Response Rate (ORR)
Overall Response Rate (ORR)
Time frame: Up to 60 months
Duration of Response (DOR)
Duration of Response (DOR)
Time frame: Up to 60 months
progression-free survival（PFS）
progression-free survival（PFS）
Time frame: Up to 60 months
Plan to share: No
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This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Jiangsu Simcere Pharmaceutical Co., Ltd.