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This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu 177-PSMA-3D1015 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu 177-PSMA-3D1015 Injection | Drug | 3D1015 is administered intravenously at an individualized dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) | Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs. | From first dose of study drug through end of treatment (~36-48 weeks) |
| Occurrence of Dose-Limiting Toxicities (DLTs) | Number of participants experiencing dose-limiting toxicities (DLTs) . | From first dose of study drug through end of treatment (~36-48 weeks) |
| Absorbed Dose | Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data. | From first dose of study drug through end of treatment (~36-48 weeks) |
| Effective Half-Life | Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging. | From first dose of study drug through end of treatment (~36-48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with a PSA change from baseline | The effect of Lu 177-PSMA-3D1015 on prostate-specific antigen (PSA) kinetics. | From first dose of study drug through end of treatment (~36-48 weeks) |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chunjing Yu | Contact | 15312238622 | ycjwxd1978@jiangnan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangnan University Affiliated Hospital | Recruiting | Wuxi | Jiangsu | China |
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Percentage of participants with a complete response (CR) or partial response (PR).
| From first dose of study drug through efficacy follow-up period (Up to approximately 5 years) |
| Radiographic progression-free survival (rPFS) | rPFS per investigator assessment. | From first dose of study drug through efficacy follow-up period (Up to approximately 5 years) |