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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07084584 | An Open-label, Dose-Escalation and Dose-Expansion Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia | PHASE1 | NOT YET_RECRUITING | 184 | — | — | Jun 10, 2026 | Oct 10, 2029 | Jul 24, 2025 | - | — |
Incidence of dose-limiting toxicities events identified
Incidence of adverse events as reported by investigators.
Plasma concentrations of GB3226
Number of subjects in complete remission or complete remission with partial hematologic recovery
| Arm | Type | Description |
|---|---|---|
| Cohort A | EXPERIMENTAL | Cohort A: Patients must not be receiving any weak, moderate, or strong CYP3A4 inhibitors/inducers. Patients who were receiving a CYP3A4 inhibitor/inducer must have discontinued the medication at least 7 days prior to enrolment |
| Cohort B | EXPERIMENTAL | Cohort B: Patients must be receiving a strong CYP3A4 inhibitor for antifungal prophylaxis (e.g. parconazole, itraconazole, ketoconazole, or voriconazole) for at least 7 days prior to enrolment and while on GB3226 treatment. Patients must not be receiving any other strong CYP3A4 inhibitors/inducers. |
| Cohort C | EXPERIMENTAL | Cohort C: Patients must be receiving a moderate CYP3A4 inhibitor for antifungal prophylaxis (e.g., isavuconazole, fluconazole) for at least 7 days prior to enrolment and while on GB3226. Patients must not be receiving any other strong or moderate CYP3A4 inhibitors/inducers. |
| Name | Type | Description |
|---|---|---|
| GB3226 | DRUG | GB3226: Dual inhibitor of ENL-YEATS and FLT3 pathways Administration: Oral, daily dosing in 28-day cycles |
Eligible participants are males and female aged 18 years or older at screening with relapsed or refractory acute myeloid leukemia Diagnosis 1. Patients in Phase 1 must have active acute myeloid leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the Nationa...