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

主要目的： 1. 评价氟[18F]思睿肽注射液 PET/CT 显像在前列腺癌生化复发患者中的诊断效能 次要目的： 1. 评价氟[18F]思睿肽注射液 PET/CT 显像在前列腺癌患者中的安全性 2. 评价氟[18F]思睿肽注射液 PET/CT 显像在不同区域（即， 前列腺、 盆腔淋巴结、 盆腔外软组织、 骨） 及不同基线 PSA 水平下对病灶的检出率 3. 评价独立阅片人盲态阅片结果的稳定性

评价177Lu-LNC1004 注射液在 FAP 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),为后续研究确定推荐剂量(Recommended PhaseII Dose,RP2D)。