Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
14C-bleximenib · 1 trial · 3 indications
Total amount excreted into the urine, expressed as a percentage of the administered dose will be reported.
Total amount excreted into the feces expressed as a percentage of the administered dose will be reported.
Aeu defined as the total amount of bleximenib and radioactivity excreted into the urine will be reported.
Aef defined as the total amount of bleximenib and radioactivity excreted into the feces will be reported.
AUC0-t in whole blood and plasma will be reported.
Maximum observed concentration in whole blood and plasma will be determined.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 14C-bleximenib | DRUG | 14C-bleximenib will be administered orally. |
| bleximenib | DRUG | Non-radiolabeled bleximenib will be administered orally. |
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, o...
14C-bleximenib is an investigational small molecule being studied for the treatment of Acute Lymphoblastic Leukemia. It is a radiolabeled form of the drug, currently in Phase 1 clinical development for this indication.
14C-bleximenib is a kinase inhibitor, as indicated by its '-nib' suffix. It is being studied in oncology, specifically for Acute Lymphoblastic Leukemia, though the specific kinase target has not been disclosed.
14C-bleximenib is being developed by Johnson & Johnson, a company traded on the NYSE under the ticker JNJ. The drug is currently in Phase 1 clinical trials.
14C-bleximenib is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in an early-stage clinical trial.
14C-bleximenib is being studied in one active Phase 1 trial, NCT07295951, titled 'A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia'. This trial is recruiting participants in the United Kingdom and has an enrollment target of 10.
14C-bleximenib is a radiolabeled form of bleximenib, used in clinical studies to track the drug's absorption, distribution, metabolism, and excretion. The radiolabeled version is specifically used in early-phase trials to understand the drug's behavior in the body.