drugset / Trial / NCT04509557
[177Lu]Ludotadipep Treatment in Patients With Metastatic Castration-resistant Prostate Cancer.
Non-randomizedSequentialOpen-labelTreatment
Summary
The study aims to evaluate the stability and efficacy after administration of \[177Lu\]Ludotadipep in patients with metastatic castration resistant prostate cancer (mCRPC), with dose-escalation applied to determine the appropriate dose.
Timeline
- Start
- 2020-10-14
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
Publications
- Background Zhou J, Neale JH, Pomper MG, Kozikowski AP. NAAG peptidase inhibitors and their potential for diagnosis and therapy. Nat Rev Drug Discov. 2005 Dec;4(12):1015-26. doi: 10.1038/nrd1903.
- Background Mease RC, Foss CA, Pomper MG. PET imaging in prostate cancer: focus on prostate-specific membrane antigen. Curr Top Med Chem. 2013;13(8):951-62. doi: 10.2174/1568026611313080008.
- Background Lutje S, Heskamp S, Cornelissen AS, Poeppel TD, van den Broek SA, Rosenbaum-Krumme S, Bockisch A, Gotthardt M, Rijpkema M, Boerman OC. PSMA Ligands for Radionuclide Imaging and Therapy of Prostate Cancer: Clinical Status. Theranostics. 2015 Oct 18;5(12):1388-401. doi: 10.7150/thno.13348. eCollection 2015.
- Background Maurer T, Eiber M, Schwaiger M, Gschwend JE. Current use of PSMA-PET in prostate cancer management. Nat Rev Urol. 2016 Apr;13(4):226-35. doi: 10.1038/nrurol.2016.26. Epub 2016 Feb 23.
- Background Haberkorn U, Eder M, Kopka K, Babich JW, Eisenhut M. New Strategies in Prostate Cancer: Prostate-Specific Membrane Antigen (PSMA) Ligands for Diagnosis and Therapy. Clin Cancer Res. 2016 Jan 1;22(1):9-15. doi: 10.1158/1078-0432.CCR-15-0820.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | [177Lu]Ludotadipep | Unknown | 1850 mbq | Intravenous |
| Subject | [177Lu]Ludotadipep | Unknown | 2775 mbq | Intravenous |
| Subject | [177Lu]Ludotadipep | Unknown | 3700 mbq | Intravenous |
| Subject | [177Lu]Ludotadipep | Unknown | 4625 mbq | Intravenous |
| Subject | [177Lu]Ludotadipep | Unknown | 5550 mbq | Intravenous |