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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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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

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Relapsed / Refractory AML Relapsed / Refractory MDS

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

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

Group Type EXPERIMENTAL

BYON4413

Intervention Type DRUG

BYON4413 will be administered by IV infusion.

Interventions

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BYON4413

BYON4413 will be administered by IV infusion.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No