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This is the first study to test SHR-1802 in humans. The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1802 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1802 | Drug | This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity | Days 1-21 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with adverse events | from the first drug administration to within 90 days for the last SHR-1802 dose | |
| Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events | At pre-defined intervals from initial dose up to 24 months |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37529157 | Derived | Deng T, Liu Z, Han Z, Zhou H, Liu R, Li Y, Li S, Xiu P, Wang S, Zhang Y, Ba Y. Safety, tolerability, and pharmacokinetics of an anti-LAG-3 antibody SHR-1802 in patients with advanced solid tumors: a phase I dose-escalation and dose-expansion study. Ther Adv Med Oncol. 2023 Jul 29;15:17588359231186025. doi: 10.1177/17588359231186025. eCollection 2023. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ORR | At pre-defined intervals from initial dose up to 24 months |
| DOR | At pre-defined intervals from initial dose up to 24 months |
| DCR | At pre-defined intervals from initial dose up to 24 months |
| PFS | At pre-defined intervals from initial dose up to 24 months |
| Maximum Concentration (Cmax) of SHR-1802 | At pre-defined intervals from initial dose through final study visit (up to 24 months) |
| Time of Maximum Concentration (Tmax) of SHR-1802 | At pre-defined intervals from initial dose through final study visit (up to 24 months) |
| Area Under the Curve (AUC) of SHR-1802 | At pre-defined intervals from initial dose through final study visit (up to 24 months) |
| Terminal Half-Life (T1/2) of SHR-1802 | At pre-defined intervals from initial dose through final study visit (up to 24 months) |
| Clearance (CL) of SHR-1802 | At pre-defined intervals from initial dose through final study visit (up to 24 months) |
| Volume of Distribution at Steady State (Vss) of SHR-1802 | At pre-defined intervals from initial dose through final study visit (up to 24 months) |
| Evaluation of the immunogenicity of SHR-1802 | Serum sampling to assess the potential for anti-drug antibody (ADA) formation. | At pre-defined intervals from initial dose through final study visit (up to 24 months) |