This is an open-label, multicenter, dose escalation and expansion Phase 1 study of SHR7280 in adult patients with hormone sensitive prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Drug: SHR7280 All participants receive SHR7280 alone.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Adverse Events(AEs)
Time frame: 30 days after last dose
Dose Limited Toxicity (DLT)
Time frame: 28 Days (first cycle)
Maximum tolerable dose (MTD)
Time frame: 28 Days (first cycle)
Recommended dose for phase II (RP2D)
Time frame: Up to 12 months
Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR7280
Time frame: 30 days after last dose
Maximum observed plasma concentration (Cmax) of SHR7280
Time frame: 30 days after last dose
Observed trough plasma concentration (Ctrough) of SHR7280
Time frame: 30 days after last dose
Time of maximum observed plasma concentration (Tmax) of SHR7280
Time frame: 30 days after last dose
Serum testosterone concentrations
Time frame: 30 days after last dose
Serum luteinizing hormone (LH) concentrations
Time frame: 30 days after last dose
Serum follicle stimulating hormone (FSH) concentrations
Time frame: 30 days after last dose
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Time to Achieve Testosterone Concentrations < 50 ng/dL
Time frame: 30 days after last dose
Percentage of Participants With Effective Castration Rate Over 24 Weeks
Time frame: Day 1 of Week 5 to Day 1 of Week 25
Percentage of Participants With Effective Castration Rate Over 48 Weeks
Time frame: 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
Time frame: Day 1 of Weeks 5, 9 and 13
Time to Prostate-Specific Antigen Progression
Time frame: 30 days after last dose