drugset / Trial / NCT04392648
A Study to Evaluate the Safety, Tolerability and Efficacy of Intravenous TAK-573 as Part of Combination Therapy in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Non-randomizedSequentialOpen-labelOther
Summary
The purpose of this study is to determine the safety, tolerability, and recommended phase 2 dose (RP2D) of TAK-573 when used with dexamethasone and in combination with bortezomib, pomalidomide, or cyclophosphamide, in participants with RRMM.
Timeline
- Start
- 2020-06-24
- Primary completion
- 2023-11-10
- Completion
- 2023-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Subcutaneous |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Oral |
| Subject | Modakafusp alfa | Protein / enzyme biologic | 0.05 mg/kg | Intravenous |
| Subject | Modakafusp alfa | Protein / enzyme biologic | 0.1 mg/kg | Intravenous |
| Subject | Modakafusp alfa | Protein / enzyme biologic | 0.75 mg/kg | Intravenous |
| Subject | Modakafusp alfa | Protein / enzyme biologic | 1.5 mg/kg | Intravenous |
| Subject | Pomalidomide | Other / unclassified | 4 mg | Oral |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Background | Dexamethasone | Small molecule | 40 mg | Oral |