drugset / Trial / NCT03276572
Phase I Trial of 225Ac-J591 in Patients With mCRPC
Phase 1
Completed
32 enrolled
Weill Medical College of Cornell University
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collabProstate Cancer Foundation · collabUnited States Department of Defense · collab
NaSingle-groupOpen-labelTreatment
Summary
This is an open-label, single-center Phase I dose escalation study designed to determine the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD) of 225Ac-J591 in a single dose regimen.
Timeline
- Start
- 2017-10-10
- Primary completion
- 2021-01-07
- Completion
- 2023-09-01
Publications
- Tagawa ST, Thomas C, Sartor AO, Sun M, Stangl-Kremser J, Bissassar M, Vallabhajosula S, Huicochea Castellanos S, Nauseef JT, Sternberg CN, Molina A, Ballman K, Nanus DM, Osborne JR, Bander NH. Prostate-Specific Membrane Antigen-Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of 225Ac-J591. J Clin Oncol. 2024 Mar 1;42(7):842-851. doi: 10.1200/JCO.23.00573. Epub 2023 Nov 3.
- Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 225Ac-J591 | Monoclonal antibody | 0.0133 mbq/kg | — |
| Subject | 225Ac-J591 | Monoclonal antibody | 0.08 mbq/kg | — |
| Subject | 225Ac-J591 | Monoclonal antibody | 0.0933 mbq/kg | — |