Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FLYSYN · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Experimental: FLYSYN | EXPERIMENTAL | IV infusion over a 3-hr duration |
| Name | Type | Description |
|---|---|---|
| FLYSYN | BIOLOGICAL | Cohort 1: Patient 1-3: FLYSYN 0.5 mg/m² BSA\* day 1 Cohort 2: Patient 4-6: FLYSYN 0.5 mg/m² BSA day 1 FLYSYN 1.0 mg/m² BSA day 2 Cohort 3: Patient 7-9: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 4.5 mg/m² BSA day 2 Cohort 4: Patient 10-12 and 13-18: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 14.5 mg/m² BSA day 2 Cohort 5: Patient 19-21: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 44.5 mg/m² BSA day 2 Cohort 6: Patient 22-24 and 25-31: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 14.5 mg/m² BSA day 2, FLYSYN 15 mg/m² BSA day 15, FLYSYN 15 mg/m² BSA day 29 \* The maximum upper limit for calculation of antibody dose is fixed at a body surface of 2.0 m², even if the calculated body surface exceeds this. In this study DLT are defined as the following treatment-related adverse events or laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. |
Inclusion Criteria: * Age ≥18 years at the time of voluntarily signing an IEC-approved informed consent, there is no upper age limit * Diagnosis of AML according to WHO criteria * Confirmed FLT3 expression on leukemic cells * Known mutational status of FLT3 (FLT3-ITD, FLT3-TKD, FLT3 wild type) * He...
FLYSYN is an investigational monoclonal antibody being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 1 clinical development, and the completed trial focused on patients with measurable residual disease (MRD) positive AML.
FLYSYN is being developed by Veraxa Biotech AG, a biopharmaceutical company. The company's ordinary shares are listed under the ticker symbol VRXA.
FLYSYN is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet been approved for commercial use.
FLYSYN has been studied in one clinical trial, identified as NCT02789254, titled 'FLYSYN in MRD Positive AML.' This Phase 1 trial was completed and enrolled 31 participants with Acute Myeloid Leukemia in Germany.
FLYSYN is the primary name used for this investigational monoclonal antibody. No alternative names have been reported for this drug candidate.