RECRUITING

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

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Conditions

Acute Myeloid LeukemiaMyelodysplastic Syndromes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A First-in-human, Phase 1, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes

Quick Facts

Study Start:2024-01-11
Study Completion:2026-10-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06146257

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants is ≥ 18 years of age at the time of signing the Informed Consent Form (ICF).
  2. * Participants must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
  3. * Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
  4. * 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.
  5. * R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapies which may provide clinical benefit.
  6. * Participants must have the following screening laboratory values:
  7. * Total white blood cell count (WBC) \< 25 x 10\^9/L prior to the first dose of the study drug.
  8. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN), unless considered due to extensive leukemic liver involvement, in which case AST and ALT can be ≤ 5.0 x ULN.
  9. * Serum total bilirubin ≤ 1.5 x ULN, unless considered due to Gilbert's syndrome, in which case serum total bilirubin \< 3 x ULN.
  10. * 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.
  11. * International normalized ratio (INR) ≤ 1.5 x ULN and active partial thromboplastin time (aPTT) ≤ 1.5 x ULN.
  12. * Life expectancy ≥ 12 weeks.
  13. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  14. * Female Participants of child-bearing potential must have a negative serum or urine pregnancy test at screening and at pre-dose on Cycle 1 Day 1 (C1D1).
  1. * Participants with acute promyelocytic leukemia (APML).
  2. * Participants with known leukemic involvement in central nervous system (CNS).
  3. * Receipt of anticancer medications/therapies within 5 half-lives or 28 days before the first administration of the study drug.
  4. * Participants with unresolved clinically significant non-hematologic toxicities of ≥ Grade 2 AE from prior therapies with exception of residual alopecia.
  5. * Participants with chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.
  6. * Participants with active malignancies other than AML or MDS.
  7. * Participants who have undergone major surgery ≤ 4 weeks prior to the first dose of the study drug.
  8. * Participants with immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection (bacterial and/or fungal), uncontrolled bleeding, and/or uncontrolled disseminated intravascular coagulation.
  9. * Participants with known chronic, active infection of hepatitis B virus (HBV), hepatitis C virus C (HCV), human immunodeficiency virus (HIV).
  10. * Participants unable to swallow oral medications, or Participants with clinically significant diarrhea, vomiting or malabsorption felt limited absorption of orally administered medications.
  11. * Participants with any other significant medical conditions, any other conditions, laboratory abnormality, or psychiatric illness which place the Participants at unacceptable risk if he/she were to participate in the study or that would hamper the Participants understanding of the study, or would prevent the Participant from complying with the study.
  12. * Medications or supplements that are known to be strong and moderate inhibitors or inducers of CYP450 isozyme 3A4 (CYP3A4) and/or P-glycoprotein (P-gp), or strong inhibitors or inducers of CYP450 isozyme 2C8 (CYP2C8) within 14 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
  13. * Pregnant or lactating women.

Contacts and Locations

Study Contact

Hongying Zhang, MD
CONTACT
619-859-4586
Hongying.Zhang@glubiotx.com

Principal Investigator

Gang Lu, Ph.D.
STUDY_DIRECTOR
GluBio Therapeutics Inc.

Study Locations (Sites)

City of Hope Medical Center
Duarte, California, 91010
United States
University of California Irvine
Irvine, California, 92697
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
United States
Alliance for Multispecialty Research, LLC
Merriam, Kansas, 66204
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
United States
Memorial Sloan Kettering Cancer Center-David H. Koch Center
New York, New York, 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: GluBio Therapeutics Inc.

  • Gang Lu, Ph.D., STUDY_DIRECTOR, GluBio Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11
Study Completion Date2026-10-08

Study Record Updates

Study Start Date2024-01-11
Study Completion Date2026-10-08

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndromes