Condition: Polycythemia Vera · Essential Thrombocythemia · Myelofibrosis · Sponsor: Hangzhou GluBio Pharmaceutical Co., Ltd.
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.
This description comes directly from the study's public registry record.
Jing Liu, Ph.D. · 86-18616699599 · Jing.Liu@glubiotx.com
Always discuss trial participation with your own doctor first.
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) | Hefei, Anhui, China | Recruiting |
| China-Japan Friendship Hospital | Beijing, Beijing Municipality, China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing, Chongqing Municipality, China | Recruiting |
| The First Hospital of Hebei Medical Universtiy | Shijiazhuang, Hebei, China | Recruiting |
| Henan Cancer Hospital | Zhengzhou, Henan, China | Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan, Hubei, China | Recruiting |
| The First Affiliated Hospital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang, Jiangxi, China | Recruiting |
| Sheng Jing Hospital of China Medical Universtiy | Shenyang, Liaoning, China | Recruiting |
| Huashan Hospital Affiliated to Fudan University | Shanghai, Shanghai Municipality, China | Recruiting |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences | Tianjin, Tianjin Municipality, China | Recruiting |
| The Second Hospital of Tianjin Medical Universtiy | Tianjin, Tianjin Municipality, China | Recruiting |
+ 2 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06378437