A Phase 1/2, First-in-Human Study of theMenin-KMT2A (MLL1)Inhibitor Bleximenib in Participants with Acute Leukemia

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506581-31-00

Acronym

75276617ALE1001

Enrollment

Registered

2023-11-02

Start date

2021-06-15

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia

Brief summary

Phase 1: Part 1 (Dose Escalation): Incidence and severity of adverse events, including dose-limiting toxicity, Phase 1: Part 2 (Dose Expansion): Incidence and severity of adverse events, Phase 2: Rate of CR/CRh assessed by the IRC.

Interventions

DRUGJNJ-75276617 (G010)

DRUGJNJ-75276617 (G001)

DRUGJNJ-75276617

DRUGJNJ-75276617 (G022)

DRUGJNJ-75276617 (G002)

DRUGJNJ-75276617 (G007)

DRUGJNJ-75276617 (G008)

DRUGJNJ-75276617 (G003)

DRUGJNJ-75276617 (G021)

DRUGJNJ-75276617 (G011)

DRUGJNJ-75276617 (G016)

DRUGJNJ-75276617 (G024)

DRUGJNJ-75276617 (G023)

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 1: Part 1 (Dose Escalation): Incidence and severity of adverse events, including dose-limiting toxicity, Phase 1: Part 2 (Dose Expansion): Incidence and severity of adverse events, Phase 2: Rate of CR/CRh assessed by the IRC.	—

Countries

Belgium, France, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026