A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
Recruiting now · Phase 1
Conditions studied: Acute Lymphoblastic Leukemia, Acute Leukemias, Acute Myeloid Leukemia
In brief
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).
Key facts
- Study ID
- NCT07295951
- Run by
- Janssen Research & Development, LLC
- People needed
- 10
- Starts
- 2025-11-18
- Expected to finish
- 2026-09-29
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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