Clinical trial · Interventional
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.
NCT06359002CI-TRIAL-00101142active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed / Refractory AML | — | UNRESOLVED | — |
| Relapsed / Refractory MDS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BYON4413 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Escalating dose cohorts of BYON4413 for patients with AML or MDS.
- interventionNames
- Drug: BYON4413
Primary outcomes (2)
- measure
- Incidence of dose-limiting toxicities (dose escalation)
- timeFrame
- 21 days
- measure
- Composite Complete Remission Rate (expansion)
- timeFrame
- Up to 24 months
- description
- CR + CRh + CRi according ELN 2022 criteria
Secondary outcomes (16)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. Key inclusion and exclusion criteria details are listed here, additional requirements may apply.
References
Publications (0)
Data not yet available
No reference posted for this study.