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

Not Applicable

Not yet recruiting

• Conditions: Relapsed/Refractory Acute Myeloid Leukemia (AML)
• Interventions: Drug: GB3226

• Registration Number: NCT07084584
• Lead Sponsor: Galecto Biotech AB

Brief 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).

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-17
• Last Update Submitted: 2025-07-17
• Study First Posted: 2025-07-24
• Last Update Posted: 2025-07-24
• Study Start: 2026-06-10
• Primary Completion: 2029-06-10
• Study Completion: 2029-10-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort A	GB3226	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	GB3226	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	GB3226	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of dose-limiting toxicities (Phase 1)	28 Days	Incidence of dose-limiting toxicities events identified
To characterize the PK parameters of GB3226	28 Days	Plasma concentrations of GB3226
To assess the safety and tolerability of GB3226	28 Days	Incidence of adverse events as reported by investigators.
To assess the complete remission and complete remission with partial hematologic recovery rate (Phase 2)	28 Days	Number of subjects in complete remission or complete remission with partial hematologic recovery