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The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-4357 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4357 injection | Drug | HRS-4357 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prog Dose limiting toxicity (DLT) | up to 9 months follow-up | |
| recommended phase 2 dose (RP2D) | up to 9 months follow-up | |
| recommended dosing cycle. | up to 9 months follow-up | |
| PSA50 response rate | up to 12 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | up to 6 weeks follow-up | |
| time to maximum plasma concentration (Tmax) | up to 6 weeks follow-up | |
| area under the plasma concentration-time curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueying Zheng | Contact | +0518-82342973 | xueying.zheng.xz17@hengrui.com |
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| up to 6 weeks follow-up |
| clearance (Cl) | up to 6 weeks follow-up |
| volume of distribution (Vz) | up to 6 weeks follow-up |
| terminal half-life (t1/2) | up to 6 weeks follow-up |
| cumulative urinary excretion of radioactive dose | up to 6 weeks follow-up |
| Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; | up to 6 weeks follow-up |
| PSA90 response rate | up to 12 weeks follow-up] |
| time to PSA progression | up to 9 months follow-up |
| Overall Response Rate (ORR) | up to 20 months follow-up |
| Disease control Rate (DCR) | up to 20 months follow-up |
| Duration of Response (DoR) | up to 20 months follow-up |
| Radiographic Progression-free Survival (rPFS) | up to 9 months follow-up |
| Overall Survival (OS) | up to 20 months follow-up |
| Incidence and severity of AEs and SAEs | up to 20 months follow-up |