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Trial Title:
Safety, Pharmacokinetics, and Preliminary Efficacy of BYON4413 in Acute Myeloid Leukemia and Myelodysplastic Neoplasms.
NCT ID:
NCT06359002
Condition:
Relapsed / Refractory AML
Relapsed / Refractory MDS
Conditions: Official terms:
Neoplasms
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Conditions: Keywords:
BYON4413
CD123
Hematologic Malignancies
Antibody Drug Conjugate
AML
MDS
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BYON4413
Description:
BYON4413 will be administered by IV infusion.
Arm group label:
Dose Escalation
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Het Ziekenhuisnetwerk Antwerpen
Address:
City:
Antwerpen
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Dimitri Breems
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Johan Maertens
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Saskia Karina Klein
Facility:
Name:
Institut Catala d'Oncologia
Address:
City:
Badalona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Susana Vives Polo
Facility:
Name:
Hospital Clinic de Barcelona
Address:
City:
Barcelona
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Jordi Esteve Reyner
Facility:
Name:
Hospital de la Santa Creu i Sant Pau
Address:
City:
Barcelona
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Ana Garrido Diaz
Facility:
Name:
Hospital San Pedro de Alcantara
Address:
City:
Caceres
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Juan Miguel Bergua Burgues
Facility:
Name:
Hospital Universitario de Salamanca
Address:
City:
Salamanca
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Maria Diez Campelo
Facility:
Name:
Hospital Universitario y Politecnico La Fe
Address:
City:
Valencia
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Pau Montesinos
Start date:
June 25, 2024
Completion date:
March 2027
Lead sponsor:
Agency:
Byondis B.V.
Agency class:
Industry
Source:
Byondis B.V.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06359002
