drugset / Trial / NCT06237491
The Safety and Dosimetry Study of 177Lu-LNC1003 Injection
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 2025-05-07
- Primary completion
- 2025-11-07
- Completion
- 2025-12-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-LNC1003 | Other / unclassified | 1110 mbq | Intravenous |
| Subject | 177Lu-LNC1003 | Other / unclassified | 1850 mbq | Intravenous |
| Subject | 177Lu-LNC1003 | Other / unclassified | 2590 mbq | Intravenous |