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

NCT07084584 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GB3226-DEV-001
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

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

Conditions

Relapsed/Refractory Acute Myeloid Leukemia (AML)

Outcome Measures

Primary Outcomes (4)

• Occurrence of dose-limiting toxicities (Phase 1)

  Incidence of dose-limiting toxicities events identified

  28 Days

• To assess the safety and tolerability of GB3226

  Incidence of adverse events as reported by investigators.

  28 Days

• To characterize the PK parameters of GB3226

  Plasma concentrations of GB3226

  28 Days

• 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

  28 Days

Study Arms (3)

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

Drug: GB3226

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.

Drug: GB3226

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.

Drug: GB3226

Interventions

GB3226 DRUG

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

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
• Adequate cardiac function defined as ejection fraction (EF) of ≥45% by echocardiogram or multigated acquisition (MUGA) scan.
• Prior Therapy:
• Prior treatment-related toxicities must have resolved to ≤Grade 1 before enrolment, except for ≤Grade 2 neuropathy or alopecia.
• Radiation therapy: ≥60 days since TBI, craniospinal, or ≥50% pelvic radiation; ≥14 days since local palliative (small port) radiation.
• Stem cell infusion: ≥90 days since HSCT and ≥4 weeks since DLI.
• Immunotherapy: ≥28 days since prior immunotherapy (including tumor vaccines) and ≥21 days since CAR T-cell or other modified T/NK cell therapy.
• Antileukemia therapy: ≥14 days or 5 half-lives (whichever is shorter) since last antileukemia therapy (e.g. small molecule, cytotoxic, or myelosuppressive therapy), unless otherwise specified. Hydroxyurea for cytoreduction can be initiated without restriction related to timing of study entry. Hydroxyurea can be continued concomitantly with GB3226. Please also refer to Appendix 6 that includes treatment options for the treatment of Differentiation Syndrome.
• Patients may receive intrathecal chemotherapy at the time of diagnostic lumbar puncture at least 24 hours prior to the start of GB3226 and may continue prophylactic intrathecal chemotherapy beginning in Cycle 2 at the treating physician's discretion.
• Hematopoietic growth factors: ≥7 days since short-acting and ≥14 days since long-acting growth factor therapy.
• Biologics: ≥90 days or 5 half-lives (whichever is shorter) since antineoplastic biologic therapy.
• Steroids: ≥7 days since systemic glucocorticoids, except for physiologic doses (≤10 mg prednisone daily) or if used as cytoreductive therapy.
• Adequate liver and kidney function i.e., i) Estimated glomerular filtration rate (GFR) based on local institutional practice (e.g., Cockcroft-Gault formula) ≥ 60 mL/min/1.73m2 ii) Adequate liver function defined as: Total bilirubin \<1.5 times the upper limit of normal (ULN) or normal conjugated bilirubin, Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<3 times ULN (unless attributed to leukemic involvement).
• Contraception

You may not qualify if:

• Patients meeting any of the following criteria are NOT eligible for study participation:
• Diagnosis
• 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.
• The following patients are required to have a lumbar puncture or Ommaya reservoir tap during the screening period:
• Signs and symptoms of CNS disease
• AML with monocytic phenotype
• WBC ≥50,000 μL at disease presentation
• History of CNS or any extramedullary disease Infection
• Detectable human immunodeficiency virus (HIV) viral load within the previous 6 months. Patients with a known history of HIV 1/2 antibodies must have viral load testing prior to study enrolment.
• Hepatitis B (defined as hepatitis B virus \[HBV\] surface antigen positive and HBV core antibody positive, or positive HBV deoxyribonucleic acid \[DNA\]).
• Hepatitis C (defined as positive hepatitis C \[HCV\] antibody with reflex to positive HCV ribonucleic acid \[RNA\]).
• NB: Patients with controlled HIV, Hep B and Hep C disease will not be excluded from study enrolment.
• Pregnancy and Breast-Feeding

Sponsors & Collaborators

• Galecto Biotech AB: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Hans Schambye, MD

CONTACT

+4570705210; Clinicaltrials@galecto.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start (Estimated): June 10, 2026
• Primary Completion (Estimated): June 10, 2029
• Study Completion (Estimated): October 10, 2029
• Last Updated: July 24, 2025

Record last verified: 2025-07