Testing Lu 177-PSMA-3D1015 Injection in Men With Advanced Prostate Cancer
Tests Lu 177-PSMA-3D1015 for safety in men with metastatic castration-resistant prostate cancer.
Plain-language title generated from the registry record
Registry title: 3D1015 Injection for Patients With mCRPC
Key facts
- Where
- Wuxi, ChinaSee the site
- Phase
- Phase 1
Where in China
- Jiangnan University Affiliated HospitalWuxi, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chunjing Yu
- Trial code
- NCT07537010
- Record updated
- 17 April 2026
- Original description
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.Read full original descriptionShow less
Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study
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.
Inclusion: Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits; Male, aged 18 years or older; Histologically or cytologically confirmed prostate adenocarcinoma; Castrate levels of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L); Must be 68Ga-PSMA PET/CT scan positive; ECOG performance status of 0 to 2; Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments; Presence of at least one metastatic lesion at baseline; Adequate Organ Function; Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).
Exclusion: Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry; Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments; Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds; Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety; Life expectancy of < 6 months, as assessed by the investigator; A superscan as seen in the baseline bone scan.