PhI GLB-001 in Pts w/ R/R AML or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

UCI Specialty Area: Cancer

Principal Investigator: Deepa Jeyakumar

Official Title: A First-in-human (FIH), Phase I, Multicenter, Open- label, Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Orally Administered GLB-001 in Patients with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) or Relapsed or Refractory Higher Risk Myelodysplastic Syndromes

A Study On:

Myeloid and Monocytic Leukemia

Other Hematopoietic

Study 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.

Eligibility

if you are at least 18 years of age

You cannot participate in this study if you are a female who is pregnant or breastfeeding or planning to become pregnant

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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