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

NCT07295951 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 75276617ALE1006
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Acute Myeloid Leukemia; Acute Leukemias; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (6)

• Percentage of Dose Excreted in Urine (feu)

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

  Up to Day 28

• Percentage of Dose Excreted in Feces (fef)

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

  Up to Day 28

• Amount Excreted in Urine (Aeu)

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

  Up to Day 28

• Amount Excreted in Feces (Aef)

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

  Up to Day 28

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

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

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

• Maximum Observed Concentration (Cmax)

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

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

Secondary Outcomes (1)

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

  Up to 58 days

Study Arms (1)

Bleximenib

EXPERIMENTAL

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.

Drug: 14C-bleximenib; Drug: bleximenib

Interventions

14C-bleximenib DRUG

14C-bleximenib will be administered orally.

Also known as: JNJ-75276617

Bleximenib

bleximenib DRUG

Non-radiolabeled bleximenib will be administered orally.

Also known as: JNJ-75276617

Bleximenib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 22, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): July 13, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)