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This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and tolerability of SHR-7367 in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-7367 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-7367 | Drug | The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicities (DLTs) | Number of participants with DLTs | Up to 3 weeks |
| Recommended phase II dose | The Recommended phase II dose of SHR-7367 injection | first dose of study medication up to 21 days |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | • Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response using RECIST 1.1 | From first dose to disease progression or death, whichever comes first, up to 12 months | |
| peak time (Tmax) | Up to 12 months | |
| peak concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China |
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The study was divided into three phases, the dose escalation phase and the dose extension phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant tumors.
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| Up to 12 months |
| area under curve from 0 to the last measurable concentration time point t (AUC0-t), | Up to 12 months |
| area under curve from 0 to infinity (AUC0-∞) | Up to 12 months |
| elimination half-life (t1/2) | Up to 12 months |
| clearance rate (CL) | Up to 12 months |
| steady-state apparent volume of distribution (Vss) | Up to 12 months |
| steady-state peak concentration (Cmax, ss) | Up to 12 months |
| steady-state valley concentration (Ctrough, ss) | Up to 12 months |
| accumulation ratio (Rac) | Up to 12 months |
| percentage of activated B lymphocyte subsets in peripheral blood | Up to 12 months |
| Immunogenicity index: drug-resistant antibody (ADA) | Up to 12 months |
| Efficacy endpoints: Objective response rate (ORR) | Up to 12 months |