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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 1

Conditions: Acute Leukemias; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia

Treatments: Drug: 14C-bleximenib; Drug: bleximenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07295951

75276617ALE1006 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Bleximenib

Experimental group

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.

Treatment:

Drug: bleximenib

Drug: 14C-bleximenib