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This study is an open-label, phase I clinical trial of SHR-A2009 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A2009 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2009 | Drug | The total dosage of SHR-A2009 was calculated according to the weight weighing results of the subjects before each administration, and was administered by intravenous drip. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) or maximum administered dose (MAD) | Incidence and category of dose limiting toxicities (DLTs) during the first cycle of SHR-A2009 treatment. | From Day 1 to 90 days after last dose |
| Recommended Phase 2 dose (RP2D) | RP2D will be determined on the basis of evaluation on MTD/MAD, PK, efficacy data in dose escalation and dose expansion stages. | From Day 1 to 90 days after last dose |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0) | Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0). | From Day 1 to 90 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Tmax of SHR-A2009 | Time to maximum concentration of SHR-A2009 | approximately 6 months |
| PK parameter: Cmax of SHR-A2009 | Maximum concentration of SHR-A2009 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital-Department of Medical Oncology | Beijing | Beijing Municipality | 100039 | China |
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Single Group Assignment
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| approximately 6 months |
| PK parameter: AUC0-t of SHR-A2009 | area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-A2009 | approximately 6 months |
| PK parameter: AUC0-∞ of SHR-A2009 | area under the concentration-time curve from time 0 to infinity of SHR-A2009 | approximately 6 months |
| Immunogenicity of SHR-A2009 | Anti-SHR-A2009 antibody (ADA) | approximately 9 months |
| Overall response rate (ORR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Duration of response (DoR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Disease control rate (DCR) | Evaluated using RECIST 1.1 | approximately within 36 months |
| Progression-free survival (PFS) | Evaluated using RECIST 1.1 | approximately within 36 months |