drugset / Trial / NCT05682443
ONC-392 Plus Lutetium Lu 177 Vipivotide Tetraxetan in Patients With mCRPC
Phase 1/2
Active not recruiting
148 enrolled
OncoC4, Inc.
Prostate Cancer Clinical Trials Consortium · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
In this Phase 2 study, mCRPC patients with PSMA positive scans who progressed on prior ARTA and up to 2 lines of taxanes, and are naïve to lutetium Lu 177 vipivotide tetraxetan, will be enrolled. The study is open-label, randomized with active control, multi-center study.
Timeline
- Start
- 2023-12-11
- Primary completion
- 2026-11-30
- Completion
- 2027-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 177Lu-PSMA-617 | Other / unclassified | — | Intravenous |
| Subject | ONC-392 | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | ONC-392 | Monoclonal antibody | 6 mg/kg | Intravenous |