NCT07084584

An Open-label, Dose-Escalation and Dose-Expansion Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of GB3226 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: Galecto Biotech AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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 leukemia. Adult patients aged ≥18 years of age are planned to be enrolled. GB3226 will be administered once daily orally (PO) in 28-day cycles, with the first study drug dose administered on Cycle 1 Day 1 (C1D1). Up to a total of three separate patient cohorts will be explored (GB3226 without a CYP3A4 inhibitor, GB3226 with a strong CYP3A4 inhibitor and, if indicated, a cohort of GB3226 with a moderate CYP3A4 inhibitor).

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia (AML)

Interventions

Type	Name	Description
DRUG	GB3226	GB3226: Dual inhibitor of ENL-YEATS and FLT3 pathways Administration: Oral, daily dosing in 28-day cycles

Timeline

• Start date: 2026-06-10
• Primary completion: 2029-06-10
• Completion: 2029-10-10
• First posted: 2025-07-24
• Last updated: 2025-07-24

Regulatory

• FDA-regulated drug study