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 developed for Acute Myeloid Leukemia, specifically in patients who are MRD positive. It is designed as a targeted therapy in the oncology setting and has been studied in a Phase 1 clinical trial. It is not yet approved for commercial use.
FLYSYN targets FLT3, a receptor tyrosine kinase. It is classified as an inhibitor of FLT3. By binding to FLT3, FLYSYN aims to interfere with signaling pathways that contribute to the survival and proliferation of leukemic cells in Acute Myeloid Leukemia.
FLYSYN is being developed by Veraxa Biotech AG, a biopharmaceutical company. Veraxa Biotech AG trades under the ticker symbol VRXA. The company is responsible for the clinical development of FLYSYN in Acute Myeloid Leukemia.
FLYSYN is in Phase 1 clinical development. It has completed one Phase 1 trial in patients with Acute Myeloid Leukemia. As an investigational product, FLYSYN has not received FDA approval and remains in clinical testing.
FLYSYN has been evaluated in a Phase 1 clinical trial, NCT02789254, titled FLYSYN in MRD Positive AML. The trial was completed and enrolled 31 participants in Germany. It was an uncontrolled, non-randomized study in adults aged 18 years and older.