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.
• 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).