A Study of GLB-001 in Patients With Myeloid Malignancies

Sponsor
Hangzhou GluBio Pharmaceutical Co., Ltd.
Study ID
NCT06378437
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia
  • Essential Thrombocythemia
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Myeloid Malignancy
  • Polycythemia Vera

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-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine 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. Approximately 108 study participants may be enrolled in the study.

Key Dates

First listed
Apr 22, 2024
Start date
May 24, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation of GLB-001 in Study Participants with PV and ET-Phase 1a
    Phase 1a (Dose Escalation) will evaluate the safety and tolerability of GLB-001 in PV and ET study participants. A standard 3+3 dose-escalation design will be applied to evaluate a set of dose levels to determine and the maximum tolerated dose (MTD) and/or recommended expansion doses (RED) in PV and ET study participants who are eligible for dose limiting toxicity (DLT) evaluation.
  • Experimental: Dose Exploration of GLB-001 in Study Participants with MF, LR-MDS, AML and HR-MDS-Phase 1b
    Phase Ib 1b (Dose Exploration) will utilize a standard 3+3 dose-escalation design to evaluate the safety and tolerability of GLB-001 in MF, LR-MDS, HR-MDS and AML study participants. The starting dose will be selected within the range of tolerated dose levels determined in Phase 1a (Dose escalation).
  • Experimental: Dose Expansion of GLB-001 in Study Participants with PV, ET, MF, LR-MDS, AML and HR-MDS-Phase 1c
    Phase 1c (Dose Expansion) will be conducted to further determine the tolerability, efficacy and the recommended phase 2 dose (RP2D) of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including PV, ET, MF, LR-MDS, HR-MDS and AML.

Primary Outcome Measure

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

Central Contacts

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