Glubio Pharmaceutical Co. Ltd.

主要目的：（1）评估GLB-001在髓系恶性肿瘤受试者中的安全性和耐受性；（2）确定GLB-001治疗髓系恶性肿瘤受试者的II期推荐剂量（RP2D）；（3）评估GLB-001在推荐扩展剂量（RED）治疗不同类型的髓系恶性肿瘤受试者的有效性。 次要目的：（1）评估GLB-001及其非对映异构体GLB-C183-A-2R在髓系恶性肿瘤受试者中的药代动力学（PK）特征；（2）初步评估GLB-001治疗髓系恶性肿瘤受试者的有效性；（3）评估GLB-001在髓系恶性肿瘤受试者中的安全性。

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.

Study GLB-002-01 is a first-in-human (FIH), phase 1, open-label, dose escalation and expansion clinical study, the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-002 monotherapy in participants with relapsed or refractory Non-Hodgkin lymphomas (R/R NHL).