NCT06359002

Brief 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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2024

Geographic Reach
3 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

June 25, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

March 26, 2024

Last Update Submit

January 16, 2026

Conditions

Relapsed / Refractory AMLRelapsed / Refractory MDS

Keywords

BYON4413CD123Hematologic MalignanciesAntibody Drug ConjugateAMLMDS

Outcome Measures

Primary Outcomes (2)

  • Incidence of dose-limiting toxicities (dose escalation)

    21 days

  • Composite Complete Remission Rate (expansion)

    CR + CRh + CRi according ELN 2022 criteria

    Up to 24 months

Secondary Outcomes (16)

  • Incidence and severity of adverse events

    Up to 24 months

  • Number of patients with dose modifications

    Up to 24 months

  • Rate of early death

    Within 3 treatment cycles

  • Maximum Plasma Concentration (Cmax) BYON4413

    Up to 24 months

  • Time to Cmax (Tmax) BYON4413

    Up to 24 months

  • +11 more secondary outcomes

Study Arms (1)

Dose Escalation

EXPERIMENTAL

Escalating dose cohorts of BYON4413 for patients with AML or MDS.

Drug: BYON4413

Interventions

BYON4413DRUG

BYON4413 will be administered by IV infusion.

Dose Escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Het Ziekenhuisnetwerk Antwerpen

Antwerp, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Location

Institut Catala d'Oncologia

Badalona, Spain

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital San Pedro de Alcantara

Cáceres, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Universitario y Politecnico La Fe

Valencia, Spain

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteRecurrenceHematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Site

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 11, 2024

Study Start

June 25, 2024

Primary Completion

September 30, 2025

Study Completion

February 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)BE(2)ES(6)