Actively Recruiting
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
Led by GluBio Therapeutics Inc. · Updated on 2026-04-13
48
Participants Needed
8
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older at the time of consent.
- Participants must voluntarily sign an informed consent form before any study procedures.
- Participants must be willing and able to follow the study visit schedule and protocol requirements.
- Participants must have a confirmed diagnosis of acute myeloid leukemia (including de novo or secondary AML) or higher-risk myelodysplastic syndromes according to 2022 WHO criteria.
- Participants must have relapsed or refractory AML or HR-MDS and have failed or be ineligible for all available beneficial therapies.
- Participants must have total white blood cell count less than 25 x 10^9/L before the first dose.
- Participants must have liver enzyme levels (AST and ALT) less than or equal to 3 times the upper limit of normal, or up to 5 times if due to extensive leukemic liver involvement.
- Participants must have serum total bilirubin less than or equal to 1.5 times the upper limit of normal, or less than 3 times if due to Gilbert's syndrome.
- Participants must have estimated serum creatinine clearance of at least 60 mL/min.
- Participants must have INR and aPTT values less than or equal to 1.5 times the upper limit of normal.
- Participants must have a life expectancy of at least 12 weeks.
- Participants must have an ECOG performance status from 0 to 2.
- Female participants of child-bearing potential must have a negative pregnancy test at screening and before the first dose.
You will not qualify if you...
- Participants with acute promyelocytic leukemia (APML).
- Participants with known leukemic involvement in the central nervous system.
- Participants who received anticancer medications or therapies within 5 half-lives or 28 days before the first study drug dose.
- Participants with unresolved clinically significant non-hematologic toxicities of grade 2 or higher from prior therapies, except residual alopecia.
- Participants with chronic graft versus host disease requiring systemic immunosuppressive therapy.
- Participants with active malignancies other than AML or MDS.
- Participants who had major surgery within 4 weeks before the first study drug dose.
- Participants with immediately life-threatening or severe leukemia complications such as uncontrolled infections, bleeding, or disseminated intravascular coagulation.
- Participants with known chronic active infections of hepatitis B, hepatitis C, or HIV.
- Participants unable to swallow oral medications or with significant diarrhea, vomiting, or malabsorption.
- Participants with other significant medical conditions, laboratory abnormalities, or psychiatric illnesses that increase risk or prevent study compliance.
- Participants using medications or supplements that strongly affect CYP3A4 or CYP2C8 enzymes within 14 days or 5 half-lives before the first dose.
- Pregnant or lactating women.
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
University of California Irvine
Irvine, California, United States, 92697
Terminated
3
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, United States, 66160
Actively Recruiting
4
Alliance for Multispecialty Research, LLC
Merriam, Kansas, United States, 66204
Terminated
5
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States, 14263
Terminated
6
Memorial Sloan Kettering Cancer Center-David H. Koch Center
New York, New York, United States, 10021
Terminated
7
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
8
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Terminated
Research Team
K
Kimberly Glen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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