GLB-001 for Acute Myeloid Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, GLB-001, in patients with certain types of blood cancer that haven't responded to other treatments. The goal is to find out how safe the drug is and what dose works best.
Will I have to stop taking my current medications?
You may need to stop taking certain medications before joining the trial, especially if they are strong or moderate inhibitors or inducers of specific enzymes (CYP3A4, CYP2C8) or P-glycoprotein. This should be done within 14 days or 5 half-lives of the medication, whichever is shorter, before starting the study drug.
What safety data exists for GLB-001 (glasdegib) in humans?
Glasdegib has been studied in combination with low-dose cytarabine for acute myeloid leukemia, and it was generally well-tolerated in clinical trials, leading to its FDA approval for certain patients. However, there are concerns about side effects when combined with other treatments, as it may affect blood-forming cells.12345
How does the drug GLB-001 differ from other treatments for acute myeloid leukemia?
GLB-001 may involve targeting the Hedgehog signaling pathway, similar to glasdegib, which is a known treatment for AML that works by inhibiting this pathway to improve survival in patients unsuitable for intensive chemotherapy. This approach is unique as it focuses on a specific molecular target, potentially offering a novel strategy for enhancing drug sensitivity in AML treatment.12678
What data supports the effectiveness of the drug GLB-001 for treating acute myeloid leukemia?
Who Is on the Research Team?
Gang Lu, Ph.D.
Principal Investigator
GluBio Therapeutics Inc.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with relapsed or refractory acute myeloid leukemia (R/R AML) or higher-risk myelodysplastic syndromes (HR-MDS). They must have failed or be ineligible for other treatments and meet specific health criteria like blood counts, liver and kidney function. Pregnant women are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Phase 1a: Evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of GLB-001 to determine the maximum tolerated dose or maximum administered dose.
Dose Expansion
Phase 1b: Confirm tolerability of selected doses and evaluate efficacy to identify minimally active dose and select recommended dose for phase 2.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GLB-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
GluBio Therapeutics Inc.
Lead Sponsor