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

Byondis

Status and phase

Active, not recruiting

Phase 1

Conditions

Relapsed / Refractory MDS

Relapsed / Refractory AML

Treatments

Drug: BYON4413

Study type

Interventional

Funder types

Industry

Identifiers

NCT06359002

2023-507781-13-00

BYON4413.001

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Key inclusion and exclusion criteria details are listed here, additional requirements may apply.