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New treatment option for Polycythemia Vera
Official title A Study of GLB-001 in Patients With Myeloid Malignancies
ClinicalTrials.gov ID: NCT06378437
What this study is testing
What is GLB-001?
GLB-001 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for polycythemia vera.
Also referred to as GLB-C183-A-2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Study participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being...
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2.
- Life expectancy \> 3 months.
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility 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)...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Shijiazhuang, Hebei, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Shijiazhuang, Hebei, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.