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| Name | Class |
|---|---|
| Shenzhen Sciprogen Bio-pharmaceutical Co., Ltd. | UNKNOWN |
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This study includes two cohorts, respectively evaluating safety, tolerability and preliminary efficacy of intravenous and subcutaneous administration of SPGL008.
This study is a study of SPGL-008 monotherapy in patients with advanced malignant tumors. The study includes two cohorts, Cohort 1 and Cohort 2 will be administered by intravenous and subcutaneous administration respectively. Both cohorts will be conducted by the dose-escalation design to evaluate safety, tolerability and preliminary efficacy of different administration of SPGL008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose level 1 of SPGL008 (Intravenous administration) | Experimental |
| |
| dose level 2 of SPGL008 (Intravenous administration) | Experimental |
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| dose level 3 of SPGL008 (Intravenous administration) | Experimental |
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| dose level 4 of SPGL008 (Intravenous administration) | Experimental |
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| dose level 5 of SPGL008 (Intravenous administration) | Experimental |
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| dose level 6 of SPGL008 (Intravenous administration) | Experimental |
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| dose level 7 of SPGL008 (Intravenous administration) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPGL008 | Drug | Biological product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(21 days) of treatment. | During the first cycle. Each cycle is 21 days |
| Maximum tolerated dose (MTD) | MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients. | During the first cycle. Each cycle is 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria. | Up to 2 years |
| Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yongsheng Li | Contact | 17784310187 | lys@cqu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| dose level 8 of SPGL008 (Intravenous administration) | Experimental |
|
| dose level 1 of SPGL008 (Subcutaneous administration) | Experimental |
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| dose level 2 of SPGL008 (Subcutaneous administration) | Experimental |
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| dose level 3 of SPGL008 (Subcutaneous administration) | Experimental |
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| dose level 4 of SPGL008 (Subcutaneous administration) | Experimental |
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| dose level 5 of SPGL008 (Subcutaneous administration) | Experimental |
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| dose level 6 of SPGL008 (Subcutaneous administration) | Experimental |
|
| Up to 2 years |
| Tmax | Up to 2 years |
| T1/2 | Up to 2 years |
| AUC | Up to 2 years |