OncoMatch/Clinical Trials/NCT06146257
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
Is NCT06146257 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GLB-001 for acute myeloid leukemia.
Treatment: GLB-001 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: all available therapies which may provide clinical benefit
R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapies which may provide clinical benefit
Cannot have received: anticancer medications/therapies
Receipt of anticancer medications/therapies within 5 half-lives or 28 days before the first administration of the study drug
Lab requirements
Blood counts
Total white blood cell count (WBC) < 25 x 10^9/L prior to the first dose of the study drug. International normalized ratio (INR) 1.5 x ULN and active partial thromboplastin time (aPTT) 1.5 x ULN.
Kidney function
Estimated serum creatinine clearance of 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated.
Liver function
AST and ALT 3.0 d7 ULN, unless considered due to extensive leukemic liver involvement, in which case AST and ALT can be 5.0 x ULN. Serum total bilirubin 1.5 x ULN, unless considered due to Gilbert's syndrome, in which case serum total bilirubin < 3 x ULN.
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. AST and ALT 3.0 d7 ULN, unless considered due to extensive leukemic liver involvement, in which case AST and ALT can be 5.0 x ULN. Serum total bilirubin 1.5 x ULN, unless considered due to Gilbert's syndrome, in which case serum total bilirubin < 3 x ULN. Estimated serum creatinine clearance of 60 mL/min using the Cockcroft-Gault equation. Measured creatinine clearance from a 24-hour urine collection is acceptable if clinically indicated. International normalized ratio (INR) 1.5 x ULN and active partial thromboplastin time (aPTT) 1.5 x ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
- University of California Irvine · Irvine, California
- University of Kansas Medical Center Research Institute, Inc. · Kansas City, Kansas
- Alliance for Multispecialty Research, LLC · Merriam, Kansas
- Roswell Park Comprehensive Cancer Center · Buffalo, New York
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