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The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1921 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1921 | Drug | Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events (AEs) | To check the numbers of AEs happened during the course of trial. | Screening up to study completion, an average of 1 year |
| Number of subjects with laboratory tests findings of potential clinical importance | To check the Clinically significant and non clinically significant abnormal values during the course of trial. | Screening up to study completion, an average of 1 year |
| Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate. | To measure the vital signs on regular basis for all study participants | Screening up to study completion, an average of 1 year |
| Measure ECG | Number of subjects with clinically significant abnormal ECG QT Interval | Screening up to study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of SHR-1921 | To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma. | Screening up to study completion, an average of 1 year |
| Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Research | Sydney | New South Wales | 2031 | Australia | ||
| Macquarie Hospital |
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SHR-1921 single arm study in pt. with Advance solid tumors
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To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma |
| Screening up to study completion, an average of 1 year |
| Time to Cmax (Tmax) of SHR-1921 | To check what time will it take to reach the maximum contraction of SHR-1921 in study participants | Screening up to study completion, an average of 1 year |
| Clearance of SHR-1921 | The apparent clearance of SHR-1921(CL/F) of SHR-1921 | Screening up to study completion, an average of 1 year |
| Terminal elimination half-life (t1/2) of SHR-1921 | To check how much time SHR-1921 will take to eliminate half of it's concentration from participants. | Screening up to study completion, an average of 1 year |
| Pharmacodynamics ("ADA" ) of SHR-1921. | To check the" Anti Drug Antibody" develops in participants against the SHR-1921 through blood sample | Screening up to study completion, an average of 1 year |
| Sydney |
| New South Wales |
| 2109 |
| Australia |
| Sydney South West Private Hospital | Sydney | New South Wales | 2170 | Australia |
| ICON Cancer Centre | Brisbane | Queensland | 4101 | Australia |