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To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH6516 tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH6516 tablets | Drug | SPH6516 tablets : Orally, once daily, 25-200mg, 28 days a cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD(Maximum tolerated dose) | Maximum tolerated dose | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration | Approximately 2 years |
| Peak Plasma Concentration (Cmax) | PK (Pharmacokinetics) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | China | ||||
| Ruijin Hospital, Shanghai Jiaotong University School Of Medicine |
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| Approximately 2 years |
| Peak time(Tmax) | PK (Pharmacokinetics) | Approximately 2 years |
| Area under the plasma concentration versus time curve (AUC) | PK (Pharmacokinetics) | Approximately 2 years |
| half-life(T1/2) | PK (Pharmacokinetics) | Approximately 2 years |
| Objective response rate(ORR) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1 | Approximately 2 years |
| Progression-free survival (PFS) | The interval between the date of the first dose of trial treatment until first documentation of disease progression or death, whichever occurs first. | Approximately 2 years |
| Shanghai |
| China |