A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Biodistribution, Radiation Dosimetry and Preliminary Efficacy of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). After confirmation of PSMA positivity, participants receive intravenous administration of 177Lu-PSMA-VG01. The objectives are: to evaluate the biodistribution, radiation dosimetry, safety and tolerability of 177Lu-PSMA-VG01 in participants; and to assess the pharmacokinetics (PK), preliminary anti-tumor activity, and in vivo stability of 177Lu-PSMA-VG01 in participants.
• Male participants aged 18 years (inclusive) to 80 years (exclusive) at the time of signing the informed consent.
• Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies, or inability to access standard treatment.
• During the screening period, imaging examinations (within 4 weeks before administration) showed the presence of ≥1 metastatic lesion.
• ECOG Performance Status score: 0 to 2.
• Expected survival time exceeds 6 months.
• All clinically significant toxicities related to prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, etc., excluding Luteinizing Hormone-Releasing Hormone (LHRH) analog therapy) must have resolved to ≤ Grade 1, except for toxicities deemed safe and manageable by the investigator, such as alopecia, peripheral neuropathy ≤ Grade 2, etc. (CTCAE V6.0).
• The participant must be fully informed about the study and voluntarily provide written informed consent prior to participation.
• The participant must be capable of understanding and complying with the requirements of the trial protocol.
• The participant must use a condom during sexual activity throughout the study period and for 14 weeks after the last dose of study treatment to prevent pregnancy in partners and potential exposure of partners to the investigational product g via semen. Additionally, the participant should refrain from sperm donation during the specified timeframe above.