GLB-001

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

What's the purpose of the trial?

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.
Trial status

Accepting patients

Phase
Phase 1
Enrollment
48
Last Updated
1 week ago
Patient Screener

For Healthcare Professionals Only

This site is intended for healthcare professionals in the US. Patients and care partners can explore and connect with MDS clinical trials through our patient portal.

Participating Centers

There are 15 centers participating in this trial. Enter a location below to find the closest center.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • GLB-001 is a kind of medication called a molecular glue degrader. This medication may work by targeting and bringing together proteins on tumor cells and proteins in the human body that break down cells.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

Dose Escalation: GLB-001

Not yet accepting

Dose Expansion: GLB-001

Real People. Real Support.

Need help connecting with this clinical trial? We're here to help!

Print a patient-friendly report to share with your patient.

We can help answer any questions and connect you (or your patient) with the study team.

Schedule a time that is convenient and we’ll call you to see how we can help you and your patient.