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

Part of paid clinical trials in Duarte, California.

Sponsor
GluBio Therapeutics Inc.
Study ID
NCT06146257
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GLB-001 — DRUG
    Administered orally according to the assigned treatment schedule

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
Apr 2026
Primary completion
Jul 1, 2026
Completion
Oct 8, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1a
    Part 1a (Dose Escalation) of the study will enroll R/R AML and R/R HR-MDS participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001 administered orally, and determine the maximum tolerated dose/maximum administered dose (MTD/MAD) in R/R AML or R/R HR-MDS patients who are eligible for dose limiting toxicity (DLT) evaluation.
  • Experimental: Dose Expansion of GLB-001 as a Monotherapy in Participants with R/R AML and R/R HR-MDS-Phase 1b
    Part 1b (Dose Expansion) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R AML and R/R HR-MDS participants.

Primary Outcome Measure

Dose-limiting Toxicity (DLT) [ Time Frame: Up to 28 days after first dose of study treatment in Phase 1a ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Brian Ball, MD
[email protected]
626-218-4784
University of California IrvineIrvineCalifornia92697-
University of Kansas Medical Center Research Institute, Inc.Kansas CityKansas66160
Jesus Gonzalez Lugo, MD
[email protected]
913-588-4138
Alliance for Multispecialty Research, LLCMerriamKansas66204-
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Lewis Silverman, MD
[email protected]
212-241-5520
Memorial Sloan Kettering Cancer Center-David H. Koch CenterNew YorkNew York10021-
University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Duarte, CA

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City of Hope Medical Center· Duarte, CAUniversity of California Irvine· Irvine, CAUniversity of Kansas Medical Center Research Institute, Inc.· Kansas City, KSAlliance for Multispecialty Research, LLC· Merriam, KSRoswell Park Comprehensive Cancer Center· Buffalo, NYIcahn School of Medicine at Mount Sinai· New York, NY

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