drugset / Trial / NCT02789254
FLYSYN in MRD Positive AML
NaSingle-groupOpen-labelTreatment
Summary
This is a first in human, prospective, multicentric, nonrandomized, open-label study to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics and immunogenicity of the Fc-optimized antibody FLYSYN as monotherapy in adult subjects.
Timeline
- Start
- 2017-02-07
- Primary completion
- 2021-09-27
- Completion
- 2021-09-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FLYSYN | Unknown | 0.5 mg/m2 | Intravenous |
| Subject | FLYSYN | Unknown | 1.5 mg/m2 | Intravenous |
| Subject | FLYSYN | Unknown | 5 mg/m2 | Intravenous |
| Subject | FLYSYN | Unknown | 15 mg/m2 | Intravenous |
| Subject | FLYSYN | Unknown | 45 mg/m2 | Intravenous |