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.
- Conditions
- Advanced or Metastatic Solid Tumors With NTRK, ROS1 or ALK Gene Fusion
- Interventions
- Registration Number
- NCT04671849
- Lead Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 243
- Adult patients with a locally advanced or metastatic solid tumor that has progressed or was nonresponsive to available therapies, are unfit for standard chemotherapy or for which no standard or available curative therapy exists；Proof of a malignancy harboring a NTRK、ROS1 or ALK fusion；Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and a life expectancy of at least 3 month；Adequate hematologic, hepatic, and renal function；Signed informed consent form；
- Any contraindications as listed in the local approved product information；Patients with unstable primary central-nervous-system tumors or metastasis, exceptions possible；Pregnancy or lactation；Clinically significant active cardiovascular disease or history of myocardial infarction；Participation in an investigational program with interventions outside of routine clinical practice；Prior treatment with other kinase inhibitor with tropomyosin receptor kinase inhibition；Active uncontrolled systemic bacterial, viral, or fungal infection；Current treatment with a strong CYP3A4 inhibitor or inducer；
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description adult patients_Dose 4 SIM1803-1A - adult patients_Dose 5 SIM1803-1A - adult patients_Dose 8 SIM1803-1A - adult patients_Dose 7 SIM1803-1A - adult patients_Dose 3 SIM1803-1A - adult patients_Dose 6 SIM1803-1A - adult patients_Dose 1 SIM1803-1A - adult patients_Dose 2 SIM1803-1A -
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to 24 hours in fasted state (AUC(0-24)_fasted) Up to 1 day 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 infinity in fasted state (AUC_fasted) Up to 3 days Area under the concentration-time curve of SIM1803-1A in plasma from time 0 to infinity in fasted state (AUC_fasted)
Number of participants with treatment-emergent adverse events (TEAEs) Up to 24 weeks Number of participants with treatment-emergent adverse events (TEAEs)
Time to maximum concentration of SIM1803-1A in plasma (Tmax) 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) Time to maximum concentration of SIM1803-1A in plasma (Tmax)
Number of participants with adverse events 5 years Number of participants with adverse events
Severity of adverse events 5 years Severity of adverse events
Maximum tolerated dose 5 years Maximum tolerated dose
Recommended dose for dose expansion 5 years Recommended dose for dose expansion
Maximum concentration of SIM1803-1A in plasma (Cmax) 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） Maximum concentration of SIM1803-1A in plasma (Cmax)
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Up to 60 months Overall Response Rate (ORR)
Duration of Response (DOR) Up to 60 months Duration of Response (DOR)
progression-free survival（PFS） Up to 60 months progression-free survival（PFS）
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, China