A Study of GLB-001 in Patients With Myeloid Malignancies
NCT ID: NCT06378437
Last Updated: 2025-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
108 participants
INTERVENTIONAL
2024-05-24
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation of GLB-001 in Study Participants with PV and ET-Phase 1a
Phase 1a (Dose Escalation) will evaluate the safety and tolerability of GLB-001 in PV and ET study participants. A standard 3+3 dose-escalation design will be applied to evaluate a set of dose levels to determine and the maximum tolerated dose (MTD) and/or recommended expansion doses (RED) in PV and ET study participants who are eligible for dose limiting toxicity (DLT) evaluation.
GLB-001
Administered orally according to the assigned treatment schedule
Dose Exploration of GLB-001 in Study Participants with MF, LR-MDS, AML and HR-MDS-Phase 1b
Phase Ib 1b (Dose Exploration) will utilize a standard 3+3 dose-escalation design to evaluate the safety and tolerability of GLB-001 in MF, LR-MDS, HR-MDS and AML study participants. The starting dose will be selected within the range of tolerated dose levels determined in Phase 1a (Dose escalation).
GLB-001
Administered orally according to the assigned treatment schedule
Dose Expansion of GLB-001 in Study Participants with PV, ET, MF, LR-MDS, AML and HR-MDS-Phase 1c
Phase 1c (Dose Expansion) will be conducted to further determine the tolerability, efficacy and the recommended phase 2 dose (RP2D) of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including PV, ET, MF, LR-MDS, HR-MDS and AML.
GLB-001
Administered orally according to the assigned treatment schedule
Interventions
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GLB-001
Administered orally according to the assigned treatment schedule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Study participants is ≥18 years of age at the time of signing the ICF.
* Study participants with confirmed diagnosis of relapsed or refractory or intolerant myeloid malignancies including PV, ET, primary myelofibrosis (PMF), MDS and AML according to 2022 World Health Organization (WHO) criteria classification, and post-polycythemia vera myelofibrosis (post-PV MF) and post-essential thrombocythemia myelofibrosis (post-ET MF) according to the 2013 IWG-MRT criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
* Life expectancy \> 3 months.
* Good performance of major organs, including hematology, liver and kidney function, and coagulation. etc.
* Study participants are willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria
* Receipt of following anticancer medications/therapies prior to the first dose of GLB-001: (1) study participants with PV or ET who received treatment with hydroxyurea within 2 days prior to the first dose, or any other treatment for PV or ET within 7 days prior to first dose of GLB-001, (2) study participants with MF who received any type of treatment for MF within 14 days prior to the first dose, such as chemotherapy, immunotherapy, radiotherapy and erythropoietin, androgens, thrombopoietin or granulocyte colony-stimulating factor, (3) study participants with LR-MDS who received any type of treatment for MDS within 14 days prior to the first dose, (4) study participants with HR-MDS or AML who received chimeric antigen receptor T cell therapy (CAR-T) or other biologic therapy within 28 days prior to the first dose of GLB-001, or received any other anticancer therapies within 14 days prior to the first dose of GLB-001.
* Receipt of any other investigational drug study within 28 days or 5 half-lives of that study drug before the first dose of GLB-001.
* Study participants with unresolved clinically significant non-hematologic toxicities that were ≥ Grade 1 or failed to recover to baseline levels following prior anticancer therapies (with the exception of alopecia or skin hyperpigmentation).
* Study participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period.
* Study participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy.
* Receipt of autologous stem cell transplantation (ASCT) within the last 3 months prior to the first dose of GLB-001, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-001.
* Study participants with known active involvement in central nervous system (CNS).
* Study participants with peripheral neuropathy ≥ Grade 2 (Graded according to CTCAE version 5.0).
* Study participants have a history of known malignancy other than the inclusion diagnosis for the past 5 years, with the exception of curatively resected cancer in situ, including cervical carcinoma in situ, basal cell carcinoma of the skin, or prostate cancer in situ, etc.
* QT interval interval \> 450 milliseconds (ms) using electrocardiographic (ECG) at screening.
* Study participants have impaired cardiac function or clinically significant cardiac disease at current or within last 6 months.
* Study participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV).
* Study participants with known human immunodeficiency virus (HIV) infection.
* Study participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases.
* Study participants with a state condition that may alter affects the absorption, distribution, metabolism and excretion of GLB-001 after judgment of the investigator.
* Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme 3A (CYP3A) and/or P-glycoprotein (P-gp), or strong inhibitors or inducers of CYP450 isozyme 2C8 (CYP2C8) within 7 days or 5 half-lives prior to the first dose of GLB-001, whichever is shorter prior to the first dose of GLB-001.
* Study participants who have undergone major surgery within 28 days prior to the first dose of the GLB-001, or unability to recover from effects of surgery.
* Pregnant or lactating women.
* Study participants who have cognitive impairment due to any psychiatric or neurological condition, including epilepsy and dementia, may limit their understanding, performance, and study compliance with the ICF.
* Study participants, in the opinion of the Investigator, who are unsuitable to participate in the study.
18 Years
ALL
No
Sponsors
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Hangzhou GluBio Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Gang Lu, Ph.D.
Role: STUDY_DIRECTOR
Hangzhou GluBio Pharmaceutical Co., Ltd.
Locations
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The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Hospital of Hebei Medical Universtiy
Shijiazhuang, Hebei, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Sheng Jing Hospital of China Medical Universtiy
Shenyang, Liaoning, China
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical Universtiy
Tianjin, Tianjin Municipality, China
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoyu Zhu, MD
Role: primary
Zhenling Li, MD
Role: primary
Li Wang, MD
Role: primary
Qingchi Liu, MD
Role: primary
Hu Zhou, MD
Role: primary
Xuelan Zuo, MD
Role: primary
Miao Miao, MD
Role: primary
Fei Li, MD
Role: primary
Wei Yang, MD
Role: primary
Wei Wang, MD
Role: primary
Lei Zhang, MD
Role: primary
Jie Bai, MD
Role: primary
Hongyan Tong, MD
Role: primary
Songfu Jiang, MD
Role: primary
Other Identifiers
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GLB-001-02
Identifier Type: -
Identifier Source: org_study_id
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