Lu 177-PSMA-3D1015 Injection: 3D1015 is administered intravenously at an individualized dose.
Study 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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Jiangnan University Affiliated Hospital
Wuxi
Jiangsu
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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