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This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS1304 tablet | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS1304 tablet | Drug | QLS1304 monotherapy dose escalation and expansion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity (DLT) of QLS1304 | up to 35 days | |
| Maximum tolerated dose(MTD)of QLS1304 | up to 35 days | |
| Recommended Phase II Dose (RP2D) of QLS1304 | up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| adverse event | from the first drug administration to within 30 days for the last treatment dose | |
| Cmax | through study completion, an average of 2 year | |
| objective response rate(ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Recruiting | Shanghai | China |
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| through study completion, assessed up to 24 months |
| Tmax | through study completion, an average of 2 year |
| AUC0-t | through study completion, an average of 2 year |
| AUC0-inf | through study completion, an average of 2 year |
| CL/F | through study completion, an average of 2 year |
| Vd/F | through study completion, an average of 2 year |
| MRT | through study completion, an average of 2 year |
| t1/2 | through study completion, an average of 2 year |