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The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1501 dose escalation | Experimental | SHR-1501 given subcutaneously |
|
| SHR-1501 dose expansion | Experimental | SHR-1501 given subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1501 | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity | Dose-limiting toxicity in patients with advanced tumors treated by SHR-1501. | Approximately 2 years |
| Maximum tolerated dose | Maximum tolerated dose in patients with advanced tumors treated by SHR-1501. | Approximately 2 years |
| Adverse event/Serious adverse event | Incidence/severity of adverse events/serious adverse events (rated based on CTC AE v5.0) | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) | Single dose: maximum concentration (Cmax) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: time to maximum concentration (Tmax) |
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Inclusion Criteria:
All Patients All patients must meet all the following criteria to be eligible to participate:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Huang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer hospital, Chinese academy of medical sciences | Beijing | 100021 | China |
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| Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: areas under the concentration-time curve (AUClast and AUCinf) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: half-life (t1/2) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: clearance (CL) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: mean residence time (MRT) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: volume at steady state (Vss) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): maximum concentration at steady state (Css_max) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable):time to maximum concentration (Tmax) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable):area under the concentration-time curve at steady state (AUCss) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): t1/2 | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable):steady-state minimum concentration at steady state (Css_min) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable):average concentration at steady state(Cavg) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable):accumulation ratio (Rac) | Approximately 2 years |
| Immune-related biomarkers | indicated by the count of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Immune-related biomarkers | indicated by the percentage of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Immune-related biomarkers | indicated by the count of natural killer (NK) cells in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Immune-related biomarkers | indicated by the percentage of natural killer (NK) cells in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Objective response rate | Percentage of participants with CR or PR. | Approximately 2 years |
| Disease control rate | Percentage of participants with CR or PR or SD. | Approximately 2 years |
| Immunogenicity | The immunogenicity of SHR-1501 single drug. The indicator includes number of participants with anti-drug antibody positive or neutralizing antibody positive. | Approximately 2 years |