The Safety and Dosimetry Study of 177Lu-LNC1004 Injection

Summary

This proposal is a phase I, open-label study of a 4-Dose Regimen of Escalating Doses of 177Lu-LNC1004 Injection in patients with recurrent or metastatic, fibroblast activation protein-positive solid tumors. In the clinical development, we aim to demonstrate the following: * 177Lu-LNC1004 Injection is safe and tolerable at therapeutic dose. * Determination of dose(s) to be used in the expansion phase. The treatment regimen will consist of a single dose intravenous administration of 177Lu-LNC1004 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 4 different dose levels

Timeline

Start

2023-10-03

Primary completion

2024-09-25

Completion

2024-09-25

Drugs

Indications