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NCT Number: NCT07295951

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

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).

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Key information

Conditions

Acute Lymphoblastic Leukemia Acute Leukemias Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

14C-bleximenib

Drug

14C-bleximenib will be administered orally.

Other names: JNJ-75276617

Bleximenib

Drug

Non-radiolabeled bleximenib will be administered orally.

Other names: JNJ-75276617

Primary outcomes

  1. Percentage of Dose Excreted in Urine (feu)

    Time frame: Up to Day 28

    Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.

  2. Percentage of Dose Excreted in Feces (fef)

    Time frame: Up to Day 28

    Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.

  3. Amount Excreted in Urine (Aeu)

    Time frame: Up to Day 28

    Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.

  4. Amount Excreted in Feces (Aef)

    Time frame: Up to Day 28

    Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.

  5. Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)

    Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)

    AUC0-t in whole blood and plasma will be reported.

  6. Maximum Observed Concentration (Cmax)

    Time frame: Cycle 1 Day 1, and Cycle 1 Day 2 (Cycle duration=28 days)

    Maximum observed concentration in whole blood and plasma will be determined.

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 58 days

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the study treatment. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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