3D1015 Injection for Patients With mCRPC

Inclusion criteria

• 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 criteria

• Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
• Life expectancy of < 6 months, as assessed by the investigator.
• A superscan as seen in the baseline bone scan.
• 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.