Radiolabeled bleximenib to track how the drug is processed in acute leukemia
An Open-Label Study to Investigate the Absorption, Metabolism, And Excretion (AME) Of 14C-Bleximenib (JNJ-75276617) in Participants With Acute Leukemia
This study will give radiolabeled bleximenib to people with relapsed or refractory acute leukemia to see how their bodies absorb, break down, and remove the drug.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Janssen Research & Development, LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Manchester) |
| Trial ID | NCT07295951 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study administers a 14C-labeled dose of bleximenib to participants with relapsed or refractory acute leukemia who carry KMT2A, NPM1, NUP98, or NUP214 gene alterations and collects timed blood, urine, and stool samples to map absorption, distribution, metabolism, and excretion. The radioactive label enables precise tracking of the parent drug and its metabolites over time using radiometric detection and analytical chemistry. Eligibility requires ECOG performance status 0–1, body weight ≥40 kg, and having exhausted or being ineligible for standard therapeutic options. Safety, tolerability, and pharmacokinetic/metabolic profiles will be analyzed to inform dosing and further development.
Who should consider this trial
Good fit: Adults with relapsed or refractory acute leukemia (≥40 kg) who harbor KMT2A, NPM1, NUP98, or NUP214 alterations, have ECOG 0–1, and have exhausted or are ineligible for available treatments are the intended participants.
Not a fit: Patients with acute promyelocytic leukemia, Down syndrome–associated leukemia, active central nervous system disease, recent solid organ transplant recipients, or those without the specified gene alterations are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the results could clarify dosing, systemic exposure, and metabolite profiles to support safer and more effective use of bleximenib in acute leukemia.
How similar studies have performed: Radiolabeled ADME studies are a well-established drug development tool and have successfully characterized pharmacokinetics for other oncology agents, but applying 14C-bleximenib specifically in acute leukemia is a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manchester
- The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: Participate-In-This-Study1@its.jnj.com
- Phone: 844-434-4210
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.