NCT06146257 A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
| NCT ID | NCT06146257 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | GluBio Therapeutics Inc. |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2026-07-01 |
Trial Parameters
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Brief Summary
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The dose escalation part (Phase 1a) of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 administered orally. Approximately 24 participants (up to 42 participants) may be enrolled in Phase 1a of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Up to 24 participants (12 participants per dose level) may be enrolled in Phase 1b of the study.
Eligibility Criteria
Inclusion Criteria: * Participants is ≥ 18 years of age at the time of signing the Informed Consent Form (ICF). * Participants must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. * Participants are willing and able to adhere to the study visit schedule and other protocol requirements. * Participants with histologically or cytologically confirmed AML including de novo AML or secondary AML transformed from MDS according to 2022 World Health Organization (WHO) criteria classification, or with histologically or cytologically confirmed HR-MDS. * R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapies which may provide clinical benefit. * Participants must have the following screening laboratory values: * Total white blood cell count (WBC) \< 25 x 10\^9/L prior to the first dose of the study drug. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN), un
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