drugset / Trial / NCT05011188
FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer
Phase 1/2
Active not recruiting
44 enrolled
Rahul Aggarwal
Fortis Therapeutics, Inc. · collabKyntra Bio · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase 1b/2 study evaluating FOR46 in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) after prior progression on abiraterone. FOR46 is designed to target and bind to CD46, a transmembrane cellular protein expressed at moderate or high levels in numerous cancer types. The investigators hypothesize that the combination of FOR46 plus enzalutamide will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients.
Timeline
- Start
- 2022-01-19
- Primary completion
- 2027-07-31
- Completion
- 2027-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FOR46 | Other / unclassified | — | Intravenous |
| Background | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Background | Pegfilgrastim | Protein / enzyme biologic | 3 mg | Subcutaneous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |