A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia
NCT ID: NCT07295951
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
10 participants
INTERVENTIONAL
2025-11-18
2026-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Bleximenib
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.
14C-bleximenib
14C-bleximenib will be administered orally.
bleximenib
Non-radiolabeled bleximenib will be administered orally.
Interventions
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14C-bleximenib
14C-bleximenib will be administered orally.
bleximenib
Non-radiolabeled bleximenib will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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The Christie NHS Foundation Trust Christie Hospital
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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75276617ALE1006
Identifier Type: OTHER
Identifier Source: secondary_id
75276617ALE1006
Identifier Type: -
Identifier Source: org_study_id