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This is a multi-center, open-label design to evaluate the safety and tolerance of QLS31905 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS31905 | Experimental | QLS31905 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS31905 | Drug | QLS31905 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities(DLTs) | Number of participants experiencing DLTs According to NCI-CTCAE v.5.0,To evaluate the safety and tolerability of QLS31905 | 2 years |
| Maximum tolerated Dose(MTD) | To evaluate the safety and tolerability of QLS31905 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Progression free survival will be determined from investigator derived tumor assessments per RECIST 1.1. | 2 years |
| Objective response rate (ORR) | Objective Response Rate (ORR) is the percentage of CR+PR |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| 2 years |
| Disease control rate (DCR) | Disease control Rate (DCR) is the percentage of CR+PR+SD | 2 years |
| adverse events (AE) | To evaluate the safety and tolerability of QLS31905 | 2 years |
| Cmax | Maximum concentration (Cmax) of the drug after administration | 2 years |
| AUC | The area under the curve (AUC) of serum concentration of the drug after the administration | 2 years |