The Safety and Dosimetry Study of 177Lu-LNC1003 Injection

This proposal is a phase I, open-label study of a 3-Dose Regimen of Escalating Doses of 177Lu-LNC1003 Injection in patients with PSMA-positive mCRPC. In the clinical development, we aim to demonstrate the following: 1. Determination of the therapeutic dose(s) to be used in the expansion phase. 2. Demonstration of the safety and tolerability of 177Lu-LNC1003 at therapeutic doses. The treatment regimen will consist of a single-dose intravenous administration of 177Lu-LNC1003 Injection per 6-week cycle, for a total of 2 cycles. The dose per cycle will be fixed for each patient and will be escalated in 3 different dose levels