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FLYSYN

Phase 1

Acute Myeloid Leukemia | Monoclonal antibody | Oncology |Veraxa Biotech AG Ordinary Shares|Last Updated: Dec 28, 2023

Success Probability
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Market & Valuation
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical trial landscape

FLYSYN · 1 trial · 1 indication

Phase 1 1
NCT02789254FLYSYN in MRD Positive AMLAcute Myeloid Leukemia
COMPLETED31 Analytics
PHASE1COMPLETED
FLYSYN in MRD Positive AML
Acute Myeloid Leukemia
NCT0278925431
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Study Endpoints
Primary Endpoints
Incidence and severity of adverse events (AE) (CTCAE V 4.03)
until 28 days (i.e. Visit7, day 29) after last dosing
Secondary Endpoints
Incidence and severity of adverse events (AE) (CTCAE V 4.03)
until 180 days (i.e.Visit 11, day 180) after last dosing
Pharmacokinetics and pharmacodynamics
Visit 1 to 13
Immunogenicity of FLYSYN based on both absolute (number and percentage of subjects who develop HAMA/HAHA) and semi-quantitative (HAMA/HAHA titer determination of confirmed positive samples) assessments
BSL; Visits 5-7;9-13
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Experimental: FLYSYNEXPERIMENTALIV infusion over a 3-hr duration
Interventions
NameTypeDescription
FLYSYNBIOLOGICALCohort 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.
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

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...

Countries:Germany
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