drugset / Trial / NCT04886986
Phase I Study of 225Ac-J591 Plus 177Lu-PSMA Small Molecule for Progressive Metastatic Castration Resistant Prostate Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a phase I dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA small molecule. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). This phase of the study (phase I) will determine the highest dose of the study intervention that can be safely given.
Timeline
- Start
- 2021-06-30
- Primary completion
- 2027-12
- Completion
- 2029-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | 6800 mbq | Intravenous |
| Subject | 177Lu-PSMA-617 | Other / unclassified | 7400 mbq | Intravenous |
| Subject | 177Lu-PSMA-I&T | Other / unclassified | 6800 mbq | Intravenous |
| Subject | 225Ac-J591 | Monoclonal antibody | 0.03 mbq/kg | Intravenous |
| Subject | 225Ac-J591 | Monoclonal antibody | 0.04 mbq/kg | Intravenous |
| Background | 68Ga-PSMA-11 | Diagnostic / imaging agent | 185 mbq | Intravenous |