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Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.
Sponsor: Byondis B.V.
Summary
This is the first-in-human trial with BYON4413 to evaluate safety, PK, immunogenicity, and anti-leukemia activity of BYON4413 in patients with AML or MDS.
Official title: A First-in-human Dose Escalation and Expansion Trial With the Antibody-drug Conjugate BYON4413 to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2024-06-25
Completion Date
2026-02
Last Updated
2026-01-20
Healthy Volunteers
No
Interventions
BYON4413
BYON4413 will be administered by IV infusion.
Locations (9)
Het Ziekenhuisnetwerk Antwerpen
Antwerp, Belgium
UZ Leuven
Leuven, Belgium
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Institut Catala d'Oncologia
Badalona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital San Pedro de Alcantara
Cáceres, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario y Politecnico La Fe
Valencia, Spain