A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

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 expans

Trial Details

NCT ID
NCT06146257
Phase
PHASE1
Sponsor
GluBio Therapeutics Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • GLB-001
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • Merriam, Kansas, United States|39.02362,-94.69357
  • Buffalo, New York, United States|42.88645,-78.87837

Key Eligibility 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…

For full eligibility, visit ClinicalTrials.gov.

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