drugset / Trial / NCT05590377
A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma
RandomizedSequentialOpen-labelTreatment
Summary
The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.
Timeline
- Start
- 2023-01-23
- Primary completion
- 2024-05-22
- Completion
- 2024-05-22
Outcome
Outcome not reported
Stopped (Enrollment): “After completion of Phase 1 Dose Escalation of this study the sponsor decided not to proceed with Phase 2a due to strategic reasons. Thus, no participants were enrolled for Phase 2a and the study was terminated early.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Modakafusp alfa | Protein / enzyme biologic | 80 mg | Intravenous |
| Subject | Modakafusp alfa | Protein / enzyme biologic | 120 mg | Intravenous |
| Subject | Modakafusp alfa | Protein / enzyme biologic | 240 mg | Intravenous |
| Background | Daratumumab | Monoclonal antibody | 1800 mg | Subcutaneous |