RecruitingPhase 1NCT06146257

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

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


Sponsor

GluBio Therapeutics Inc.

Enrollment

48 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests a new drug called GLB-001 in adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (MDS) — blood cancers that have come back or stopped responding to other treatments. **You may be eligible if...** - You are 18 or older with AML or high-risk MDS confirmed by lab testing - Your cancer has relapsed or has not responded to all available treatments - Your overall health and performance status allow you to participate (ECOG 0–2) - Your liver, kidney, and clotting function meet minimum standards - You have a life expectancy of at least 12 weeks **You may NOT be eligible if...** - You have a type of leukemia called acute promyelocytic leukemia (APML) - Your leukemia has spread to the brain or spinal cord - You have taken anticancer therapies in the past month - You have chronic graft-versus-host disease requiring immune-suppressing drugs - You have another active cancer besides AML or MDS - You have had recent major surgery (within 4 weeks) - You have active HIV, Hepatitis B, or Hepatitis C - You are pregnant or breastfeeding - You cannot swallow oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGLB-001

Administered orally according to the assigned treatment schedule


Locations(8)

City of Hope Medical Center

Duarte, California, United States

University of California Irvine

Irvine, California, United States

University of Kansas Medical Center Research Institute, Inc.

Kansas City, Kansas, United States

Alliance for Multispecialty Research, LLC

Merriam, Kansas, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center-David H. Koch Center

New York, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06146257


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