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This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLF31907 in combination with Irinotecan | Experimental |
| |
| QLF31907 in combination with Docetaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLF31907 | Drug | intravenous administration, once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| phase Ib: Dose-limiting toxicity(DLT) | The DLT of QLF31907 combination therapy will be determined | 28 days |
| phase2: objective response rate(ORR) | the ORR of QLF31907 combinaton therapy will be determined | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events (AEs) of QLF31907 combination therapy | to evaluate the severity, incidence and causality of adverse events (AEs) | up to 2 years |
| area under the concentration-time curve (AUC) of QLF31907 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen | Contact | 010-88196561 | doctorshenlin@sina.cn |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
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| Irinotecan | Drug | intravenous administration, 125 mg/m2, d1 and d8, every 3 weeks |
|
| Docetaxel | Drug | intravenous administration, 75mg/m2, d1, every 3 weeks |
|
the area under the concentration-time curve (AUC) of QLF31907 will be determined
| up to 2 years |
| Immunogenicity of QLF31907 | the anti-drug antibody(ADA) against QLF31907 will be determined | up to 2 years |
| overall survival(OS) | the OS of QLF31907 combination therapy will be determined | up to 2 years |
| maximum plasma concentration (Cmax) of QLF31907 | the maximum plasma concentration (Cmax) of QLF31907 will be determined | up to 2 years |
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |