A Study of GLB-001 in Patients With Myeloid Malignancies

Launched by HANGZHOU GLUBIO PHARMACEUTICAL CO., LTD. · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial, called GLB-001-02, is investigating a new treatment called GLB-001 for patients with certain blood cancers known as myeloid malignancies. These include conditions like polycythemia vera, essential thrombocythemia, myelofibrosis, myelodysplastic syndromes, and acute myeloid leukemia. The study is designed to assess how safe GLB-001 is, how well it works, and how the body processes it. The trial is open to about 108 participants aged 18 and older who have previously received other treatments but may not have seen success.

To be eligible, participants must have a confirmed diagnosis of one of these conditions and be well enough to participate, meaning they should have a good performance status and be able to attend study visits. They will take GLB-001 by mouth and will be monitored closely to assess its effects. It’s important to note that certain people, such as those with specific recent treatments or serious health issues, may not be able to join the study. If you're interested, you would need to provide informed consent, meaning you fully understand the trial and agree to participate.

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Eligibility criteria

• Inclusion Criteria:
• • Study participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
• • 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:
• • Study participants with acute promyelocytic leukemia (APL).
• • 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.