nctId: NCT06378437 id: GLB-001-02 briefTitle: A Study of GLB-001 in Patients With Myeloid Malignancies overallStatus: NOT_YET_RECRUITING date: 2024-04-22 date: 2026-12-31 date: 2027-12-31 date: 2024-04-22 date: 2024-04-22 name: Hangzhou GluBio Pharmaceutical Co., Ltd. class: INDUSTRY briefSummary: 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 conditions: Essential Thrombocythemia conditions: Myelofibrosis conditions: Myelodysplastic Syndromes conditions: Acute Myeloid Leukemia conditions: Myeloid Malignancy studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 108 type: ESTIMATED name: GLB-001 measure: Dose-limiting Toxicity (DLT) measure: Maximum Tolerated Dose (MTD) measure: Recommended Expansion Doses (RED) measure: Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs) measure: Recommended Phase 2 Dose (RP2D) measure: Response Assessment in Study Participants With PV measure: Response Assessment in Study Participants With ET measure: Response Assessment in Study Participants With MF measure: Response Assessment in Study Participants With LR-MDS measure: Response Assessment in Study Participants With HR-MDS measure: Response Assessment in Study Participants With AML measure: GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2 measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax] measure: GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Henan Cancer Hospital city: Zhengzhou state: Henan zip: 450003 country: China name: Hu Zhou, MD role: CONTACT phone: 86-0371-65587320 lat: 34.75778 lon: 113.64861 facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences city: Tianjin state: Tianjin zip: 300020 country: China name: Lei Zhang, MD role: CONTACT phone: 86-022-23909240 lat: 39.14222 lon: 117.17667 facility: The First Affilicated Hospital, Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310003 country: China name: Hongyan Tong, MD role: CONTACT phone: 86-0571-87236114 lat: 30.29365 lon: 120.16142 hasResults: False