Condition: Acute Myeloid Leukemia · Myelodysplastic Syndromes · Sponsor: GluBio Therapeutics Inc.
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.
This description comes directly from the study's public registry record.
Kimberly Glen · 984-260-8186 · Kimberly.glen@glubiotx.com
Always discuss trial participation with your own doctor first.
| City of Hope Medical Center | Duarte, California, United States | Recruiting |
| University of California Irvine | Irvine, California, United States | Terminated |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City, Kansas, United States | Recruiting |
| Alliance for Multispecialty Research, LLC | Merriam, Kansas, United States | Terminated |
| Roswell Park Comprehensive Cancer Center | Buffalo, New York, United States | Terminated |
| Memorial Sloan Kettering Cancer Center-David H. Koch Center | New York, New York, United States | Terminated |
| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
| University of Texas M. D. Anderson Cancer Center | Houston, Texas, United States | Terminated |
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Source record: clinicaltrials.gov/study/NCT06146257