Trials / Active Not Recruiting
Active Not RecruitingNCT06359002
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.
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Byondis B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BYON4413 | BYON4413 will be administered by IV infusion. |
Timeline
- Start date
- 2024-06-25
- Primary completion
- 2025-09-30
- Completion
- 2026-02-01
- First posted
- 2024-04-11
- Last updated
- 2026-01-20
Locations
9 sites across 3 countries: Belgium, Netherlands, Spain
Source: ClinicalTrials.gov record NCT06359002. Inclusion in this directory is not an endorsement.