Study of Safety, Pharmacokinetics, and Radiation Dosimetry of 68Ga177Lu-BRP-020063 in Adults with Advanced Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics, biodistribution, and radiation dosimetry of the investigational drug 68Ga177Lu-BRP-020063 in patients with advanced metastatic solid tumors, with a focus on urothelial carcinoma and breast cancer. This early-phase, open-label, single-arm trial also aims to preliminarily explore the therapeutic effects of this drug. The study plans to enroll 10 patients for PETCT imaging and select 5 patients with positive imaging results for treatment with a low dose of the investigational drug. Participants will first receive a diagnostic phase involving a single intravenous injection of 68Ga-BRP-020063 followed by PETCT scans. Those who test positive will then receive a therapeutic phase consisting of a single intravenous infusion of 177Lu-BRP-020063 over about 20 minutes. The doses are carefully controlled within specified ranges and followed by saline flushes. This approach will help researchers understand drug behavior and safety before considering higher doses in future studies. During the trial, patients will be closely monitored for adverse events from enrollment to four weeks after the first dose. Researchers will assess pharmacokinetics, biodistribution, and radiation dosimetry for up to 168 hours after administration. Participants will undergo imaging, laboratory tests, and safety evaluations throughout the study. The total participation duration covers initial diagnostic imaging, treatment, and follow-up safety monitoring to gather comprehensive data on the investigational drugs impact.

Safety and Tolerability Study of 68Ga/177Lu-BRP-020063 in Advanced Solid Tumors