Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemias | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 14C-bleximenib | Drug | — | UNRESOLVED |
| bleximenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bleximenib
- description
- Participants will receive a single oral dose of 14C-bleximenib on Cycle 1 Day 1. The recommended Phase 2 dose (RP2D) of bleximenib will start on Cycle 1 Day 2 with non-radiolabeled bleximenib and will continue until the end of Cycle 1 (cycle duration=28 days), with subsequent roll-over for eligible participants to 75276617ALE1001 (NCT04811560) for continued non-radiolabeled bleximenib administration as appropriate.
- interventionNames
- Drug: 14C-bleximenib
- Drug: bleximenib
Primary outcomes (6)
- measure
- Percentage of Dose Excreted in Urine (feu)
- timeFrame
- Up to Day 28
- description
- Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
- measure
- Percentage of Dose Excreted in Feces (fef)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available