Metastatic Castration-resistant Prostate Cancer, mCRPC
Conditions
Brief summary
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.
Interventions
DRUGLu 177-PSMA-3D1015 Injection
3D1015 is administered intravenously at an individualized dose.
Sponsors
Chunjing Yu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits. 2. Male, aged 18 years or older. 3. Histologically or cytologically confirmed prostate adenocarcinoma. 4. Castrate levels of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). 5. Must be 68Ga-PSMA PET/CT scan positive. 6. ECOG performance status of 0 to 2. 7. Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments. 8. Presence of at least one metastatic lesion at baseline. 9. Adequate Organ Function. 10. Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).
Exclusion criteria
1. Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry. 2. Life expectancy of \< 6 months, as assessed by the investigator. 3. A superscan as seen in the baseline bone scan. 4. Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments. 5. Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds. 6. Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug through end of treatment (~36-48 weeks) | Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs. |
| Occurrence of Dose-Limiting Toxicities (DLTs) | From first dose of study drug through end of treatment (~36-48 weeks) | Number of participants experiencing dose-limiting toxicities (DLTs) . |
| Absorbed Dose | From first dose of study drug through end of treatment (~36-48 weeks) | Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data. |
| Effective Half-Life | From first dose of study drug through end of treatment (~36-48 weeks) | Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with a PSA change from baseline | From first dose of study drug through end of treatment (~36-48 weeks) | The effect of Lu 177-PSMA-3D1015 on prostate-specific antigen (PSA) kinetics. |
| Objective Response Rate (ORR) | From first dose of study drug through efficacy follow-up period (Up to approximately 5 years) | Percentage of participants with a complete response (CR) or partial response (PR). |
| Radiographic progression-free survival (rPFS) | From first dose of study drug through efficacy follow-up period (Up to approximately 5 years) | rPFS per investigator assessment. |
Countries
China
Contacts
CONTACTchunjing Yu
Outcome results
None listed