Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07295951 | A Study of 14C-Bleximenib (Radiolabeled) in Participants With Acute Leukemia | PHASE1 | RECRUITING | 10 | — | — | Nov 18, 2025 | Jul 13, 2026 | Jun 5, 2026 | 1 | United Kingdom |
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...