Phase 1 Study of 3D1015 Injection for Treating Metastatic Castration-Resistant Prostate Cancer in Adult Males Evaluating Safety, Dosage, and Early Effectiveness

What this Trial Is About

Researchers are evaluating 3D1015 Injection Lu 177-PSMA-3D1015 in adult males with prostate-specific membrane antigen PSMA-positive metastatic castration-resistant prostate cancer mCRPC. This open-label clinical study aims to assess the safety, tolerability, and dosimetry of the injection while also exploring its preliminary anti-tumor effects and the best dosing strategy. The study is led by Chunjing Yu and focuses on patients with advanced prostate cancer who have shown progression despite prior treatments. Participants will receive intravenous infusions of the 3D1015 drug, with doses tailored individually to optimize safety and outcomes. The treatment period lasts approximately 36 to 48 weeks, during which the dose and schedule may be adjusted. This is a phase 1 study without placebo or control groups, focusing on detailed monitoring of treatment effects and side effects. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor the absorbed radiation dose, effective half-life of the drug, and any adverse events. Researchers will also track prostate-specific antigen PSA changes, tumor response rates, and progression-free survival for up to five years. Safety and treatment effects will be carefully recorded throughout treatment and follow-up periods, with total participation lasting several years for ongoing evaluation.

3D1015 Injection for Patients With mCRPC