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Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms. | Clinical Trials | Clareo Health

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

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.

NCT06359002•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.

Detailed Description

This trial includes two parts. Part 1 is a dose escalation study in which the maximum tolerated dose and recommended dose for expansion of BYON4413 will be determined. Part 2 is an expansion study to evaluate the anti-leukemia activity and safety of BYON4413.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients who have progressed on standard therapy or have no established alternative treatment, with a diagnosis of:
•* R/R AML (WHO 2022) OR
•* MDS (WHO 2022) with ≥10% blasts in BM and have received ≥3 cycles of HMA
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
•Adequate baseline organ function.

Exclusion Criteria

•Having been treated with any CD123-targeting therapies;
•Having received allogeneic hematopoietic stem cell transplantation within 100 days prior to start Cycle 1 Day 1;
•Having treatment-related toxicities from prior anti-leukemia therapies that have not resolved to CTCAE Grade ≤ 1;
•Having active central nervous system AML or AML of the APL/M3 subtype;
•History of keratitis;
•History of specified lung or renal disease;
•Having clinically significant cardiovascular disease;
•Known infection of Hepatitis B, C or E.

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

Key Dates

Start Date

June 25, 2024

Primary Completion Date

September 30, 2025

Completion Date

February 1, 2026

Last Updated

January 20, 2026

Enrollment

ACTUAL participants

Conditions

Relapsed / Refractory AMLRelapsed / Refractory MDS

Interventions

BYON4413

DRUG

Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax

NCT07471841

IDH1 MutationRelapsed / Refractory AML

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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