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ACTIVE NOT RECRUITING
NCT06359002
PHASE1

Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.

Sponsor: Byondis B.V.

View on ClinicalTrials.gov

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

DRUG

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