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This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR7280 Does Escalation and Expansion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR7280 | Drug | Drug: SHR7280 All participants receive SHR7280 alone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events(AEs) | 30 days after last dose | |
| Dose Limited Toxicity (DLT) | 28 Days (first cycle) | |
| Maximum tolerable dose (MTD) | 28 Days (first cycle) | |
| Recommended dose for phase II (RP2D) | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280 | 30 days after last dose | |
| Maximum observed plasma concentration (Cmax) of SHR7280 | 30 days after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
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Open-label, Multicenter, Singel Group
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| Observed trough plasma concentration (Ctrough) of SHR7280 | 30 days after last dose |
| Time of maximum observed plasma concentration (Tmax) of SHR7280 | 30 days after last dose |
| Serum testosterone concentrations | 30 days after last dose |
| Serum luteinizing hormone (LH) concentrations | 30 days after last dose |
| Serum follicle stimulating hormone (FSH) concentrations | 30 days after last dose |
| Time to Achieve Testosterone Concentrations < 50 ng/dL | 30 days after last dose |
| Percentage of Participants With Effective Castration Rate Over 24 Weeks | Day 1 of Week 5 to Day 1 of Week 25 |
| Percentage of Participants With Effective Castration Rate Over 48 Weeks | Day 1 of Week 5 to Day 1 of Week 49 |
| Percentage of Serum Prostate-Specific Antigen Concentration Change frome Baseline at the End of Weeks 4, 8, 12 | Day 1 of Weeks 5, 9 and 13 |
| Time to Prostate-Specific Antigen Progression | 30 days after last dose |