Clinical Trial

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

Recruiting Early Phase 1
View on ClinicalTrials.gov →
Summary
This study is an open-label, single-arm, interventional clinical trial designed to investigate the safety of ⁶⁸Ga/¹⁷⁷Lu-BRP-020063 in patients with advanced metastatic solid tumors; to evaluate the pharmacokinetics, biodistribution, and radiation dosimetry of ¹⁷⁷Lu-BRP-020063 in patients with metastatic solid tumors; and to preliminarily explore its therapeutic efficacy. The study plans to enroll 10 patients to receive ⁶⁸Ga-BRP-020063 PET/CT imaging, among whom 5 patients positive for ⁶⁸Ga-BRP-020063 will be selected to receive a low dose of ¹⁷⁷Lu-BRP-020063. The results of this study will provide a basis for the design of subsequent studies involving higher doses of ¹⁷⁷Lu-BRP-020063.
Protocol Amendment History 1 change
critical Recruitment opened 2026-06-04
Trial Details
NCT Number NCT07439120
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Urothelial Carcinoma (UC)
Enrollment 10 participants
Start Date 2026-04-13
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-03