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