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A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia

NCT07295951•Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess how the body absorbs, breaks down (metabolism), and removes (excretes) radiolabeled bleximenib (a drug molecule that has been chemically bonded with a radioactive isotope which emits radiation making it easier to track in the body) in participants with acute leukemia (highly aggressive blood cancer typically characterized by large numbers of immature white blood cells in the bone marrow).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Body weight greater than or equal to (\>=) 40 kilograms (kg)
•Relapsed or refractory (R/R) acute leukemia harboring histone-lysine N-methyltransferase 2A (KMT2A), nucleophosmin 1 (NPM1), nucleoporin 98 (NUP98) or nucleoporin 214 (NUP214) gene alterations, and has exhausted, or is ineligible for available therapeutic options
•Eastern cooperative oncology group (ECOG) performance status grade of 0 or 1
•Regular bowel movements (that is \[i.e.\], average production of at least one stool every 2 days)
•A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin at screening and within 48 hours prior to the first dose of study treatment

Exclusion Criteria

•Acute promyelocytic leukemia or diagnosis of Down syndrome associated leukemia, according to world health organization (WHO) 2016 criteria
•Active central nervous system (CNS) disease
•Recipient of solid organ transplant
•Any toxicity (except for alopecia, stable peripheral neuropathy, thrombocytopenia, neutropenia, anemia) from previous anticancer therapy that has not resolved to baseline or to Grade 1 or less
•Major surgery (e.g., requiring general anesthesia) within 2 weeks prior to first dose of study treatment or has not recovered from surgery or has major surgery planned during the time the participant is receiving study treatment

Locations (1)

The Christie NHS Foundation Trust Christie Hospital

Manchester, United Kingdom

Key Dates

Start Date

November 18, 2025

Primary Completion Date

June 14, 2026

Completion Date

July 13, 2026

Last Updated

March 13, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Lymphoblastic LeukemiaAcute LeukemiasAcute Myeloid Leukemia

Interventions

14C-bleximenib

DRUG

bleximenib

DRUG

Contacts

Study Contact

CONTACT

844-434-4210 Participate-In-This-Study1@its.jnj.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

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