Trials / Recruiting
RecruitingNCT06378437
A Study of GLB-001 in Patients With Myeloid Malignancies
A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (estimated)
- Sponsor
- Hangzhou GluBio Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Polycythemia Vera
- Essential Thrombocythemia
- Myelofibrosis
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
- Myeloid Malignancy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GLB-001 | Administered orally according to the assigned treatment schedule |
Timeline
- Start date
- 2024-05-24
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2024-04-22
- Last updated
- 2025-08-19
Locations
14 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06378437. Inclusion in this directory is not an endorsement.