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New treatment option for Acute Myeloid Leukemia
Official title A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes
ClinicalTrials.gov ID: NCT06146257
What this study is testing
What is GLB-001?
GLB-001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as GLB-C183-A-2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapies which may provide clinical benefit.
You likely can't join if
- Participants with acute promyelocytic leukemia (APML).
- Participants with known leukemic involvement in central nervous system (CNS).
- Receipt of anticancer medications/therapies within 5 half-lives or 28 days before the first administration of the study drug.
- Participants with unresolved clinically significant non-hematologic toxicities of ≥ Grade 2 AE from prior therapies with exception of residual...
- Participants with chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.
- Participants with active malignancies other than AML or MDS.
See the full 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 Health Organization (WHO) criteria classification, or with...
- R/R AML and R/R HR-MDS who have failed or are ineligible for all available therapies which may provide clinical benefit.
- 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.
- 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.
- 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.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- 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).
- Participants with acute promyelocytic leukemia (APML).
- Participants with known leukemic involvement in central nervous system (CNS).
- Receipt of anticancer medications/therapies within 5 half-lives or 28 days before the first administration of the study drug.
- Participants with unresolved clinically significant non-hematologic toxicities of ≥ Grade 2 AE from prior therapies with exception of residual alopecia.
- Participants with chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.
- Participants with active malignancies other than AML or MDS.
- Participants who have undergone major surgery ≤ 4 weeks prior to the first dose of the study drug.
- Participants with immediately life-threatening, severe complications of leukemia such as disseminated/uncontrolled infection (bacterial and/or fungal), uncontrolled bleeding, and/or uncontrolled disseminated...
- Participants with known chronic, active infection of hepatitis B virus (HBV), hepatitis C virus C (HCV), human immunodeficiency virus (HIV).
- Participants unable to swallow oral medications, or Participants with clinically significant diarrhea, vomiting or malabsorption felt limited absorption of orally administered medications.
- 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...
- 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)...
- Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Kansas City, Kansas, United States
- Merriam, Kansas, United States
- Buffalo, New York, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Kansas City, Kansas, United States; Merriam, Kansas, United States; Buffalo, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.