Yantai Lannacheng Biotechnology Co., Ltd.

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

1)评价18F-LNC1007注射液的药代动力学特征; 2)评价18F-LNC1007注射液的生物分布和辐射剂量学; 3)初步评价18F-LNC1007注射液的安全性;

评价177Lu-LNC1008注射液在整合素αvβ3阳性的晚期恶性实体瘤患者中的安全性和耐受性、观察剂量限制性毒性（DLT）、最大耐受剂量（MTD），为II期研究确定推荐剂量（RP2D）