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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adult patients_Dose 1 | Experimental |
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| adult patients_Dose 2 | Experimental |
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| adult patients_Dose 3 | Experimental |
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| adult patients_Dose 4 | Experimental |
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| adult patients_Dose 5 | Experimental |
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| adult patients_Dose 6 | Experimental |
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| adult patients_Dose 7 | Experimental |
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| adult patients_Dose 8 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIM1803-1A | Drug | SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Number of participants with adverse events | 5 years |
| Severity of adverse events | Severity of adverse events | 5 years |
| Maximum tolerated dose | Maximum tolerated dose | 5 years |
| Recommended dose for dose expansion | Recommended dose for dose expansion | 5 years |
| Maximum concentration of SIM1803-1A in plasma (Cmax) | 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) |
| 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) | 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) | Up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall Response Rate (ORR) | Up to 60 months |
| Duration of Response (DOR) | Duration of Response (DOR) | Up to 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhen zhou, MD | Contact | 021-22200000 | jenniferzhou1116@163.com |
| Name | Affiliation | Role |
|---|---|---|
| shun lu, Ph.D | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Shanghai | China |
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| Number of participants with treatment-emergent adverse events (TEAEs) |
Number of participants with treatment-emergent adverse events (TEAEs) |
| Up to 24 weeks |
| Time to maximum concentration of SIM1803-1A in plasma (Tmax) | 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) |
| progression-free survival(PFS) | progression-free survival(PFS) | Up to 60 months |