Study GB3226-DEV-001 is a Phase 1/2, open-label, dose-escalation and expansion study of GB3226 in the treatment of relapsed or refractory acute myeloid leukaemia
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 National Comprehensive Cancer Network (NCCN) in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines, Version 3.2024).
Phase 2 patients must have documented active acute leukemia (bone marrow blasts ≥5% or reappearance of blasts in peripheral blood) as defined by the NCCN Guidelines for Acute Myeloid Leukemia (Version 3.2024) and may have specific genetic profiles.
Recurrent or refractory AML, as defined by standardized criteria (for example, European LeukemiaNet criteria (Döhner 2022); International Working Group criteria (Cheson 2003)) after standard of care therapy, including but not limited to one or two cycles of intensive chemotherapy, or venetoclax combinations. Patients with persistent leukemia after initial therapy or with recurrence of leukemia at any time after achieving a response during or after the course of treatment (including allogeneic HSCT) are eligible. Refractory or relapsed leukemia is defined by presence of ≥5% blasts in the bone marrow and/or persistence or reappearance of peripheral blasts. Patients who, upon central review, have <5% blasts in the bone marrow at baseline may be replaced to ensure enough patients for the efficacy analyses.
White blood cell (WBC) count below 25,000/μL at time of enrolment. Patients may receive cytoreduction prior to enrolment per 12 and 15
Diagnosis of active acute promyelocytic leukemia. (APML)
Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
Active CNS disease (cytology, such as any blasts on cytospin, or radiography). Patients who have cleared CNS disease by at least one negative tap prior to dosing may be enrolled, and prophylactic intrathecal chemotherapy may be continued while on trial.
Signs and symptoms of CNS disease
Sequential
GB3226
DrugGB3226: Dual inhibitor of ENL-YEATS and FLT3 pathways Administration: Oral, daily dosing in 28-day cycles
Occurrence of dose-limiting toxicities (Phase 1)
Incidence of dose-limiting toxicities events identified
To assess the safety and tolerability of GB3226
Incidence of adverse events as reported by investigators.
To characterize the PK parameters of GB3226
Plasma concentrations of GB3226
To assess the complete remission and complete remission with partial hematologic recovery rate (Phase 2)
Number of subjects in complete remission or complete remission with partial hematologic recovery
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