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A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies
Led by Hangzhou GluBio Pharmaceutical Co., Ltd. · Updated on 2025-08-19
108
Participants Needed
14
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating GLB-001, an oral drug, in patients with relapsed, refractory, or intolerant myeloid malignancies including polycythemia vera, essential thrombocythemia, myelofibrosis, various myelodysplastic syndromes, and acute myeloid leukemia. This phase 1, open-label study aims to assess the safety, tolerability, how the drug moves through and affects the body, and early signs of efficacy. The study includes three parts: dose escalation, dose exploration, and dose expansion to find the best dose for future studies. The study involves giving GLB-001 orally to participants in three phases. Phase 1a uses a dose-escalation design to evaluate safety and tolerability in patients with polycythemia vera or essential thrombocythemia. Phase 1b also uses dose escalation to study safety in patients with myelofibrosis, myelodysplastic syndromes, and acute myeloid leukemia. Phase 1c expands dosing to further assess tolerability, efficacy, and to select the recommended dose for phase 2 trials. Dose levels and treatment schedules are adjusted based on participant response and safety. Participants will undergo assessments to monitor dose-limiting toxicities within 28 days of the first dose and longer-term safety up to three years. Researchers will evaluate drug levels in the body and clinical responses to treatment over periods ranging from weeks to years depending on the disease type and study phase. Major organ functions, blood tests, adverse events, and response to treatment will be closely monitored throughout the study. Participants must agree to follow the visit schedule and study requirements during their involvement.
CONDITIONS
Brief Title
A Study of GLB-001 in Patients With Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign informed consent before any study procedures
- Be 18 years of age or older at consent
- Have a confirmed diagnosis of relapsed, refractory, or intolerant myeloid malignancies including PV, ET, primary myelofibrosis, MDS, AML, post-PV MF, or post-ET MF
- Have an ECOG performance status of 0, 1, or 2
- Have a life expectancy greater than 3 months
- Have good major organ function including hematology, liver, kidney, and coagulation
- Be willing and able to follow study visits and protocol requirements
You will not qualify if you...
- Have acute promyelocytic leukemia (APL)
- Received certain anticancer treatments within specified timeframes before first dose of GLB-001, including hydroxyurea, chemotherapy, immunotherapy, radiotherapy, CAR-T, or biologic therapies
- Participated in other investigational drug studies within 28 days or 5 half-lives before first dose
- Have unresolved significant non-hematologic toxicities of Grade 1 or higher
- Scheduled to receive other anticancer or investigational drugs during the study
- Have active graft versus host disease requiring immunosuppressive therapy
- Had stem cell transplantation within past 3 to 6 months
- Have known active central nervous system involvement
- Have peripheral neuropathy of Grade 2 or higher
- Have history of other malignancies within past 5 years except certain in situ cancers
- Have prolonged QT interval (>450 ms) on ECG
- Have impaired cardiac function or significant cardiac disease within last 6 months
- Have active infections with hepatitis B, hepatitis C, or HIV
- Have uncontrolled active systemic infections unrelated to hematologic malignancies
- Have conditions affecting drug absorption or metabolism
- Use strong/moderate CYP3A or CYP2C8 inhibitors or inducers within 7 days before dosing
- Had major surgery within 28 days before first dose or not recovered from surgery effects
- Pregnant or lactating women
- Have cognitive impairment limiting study compliance
- Considered unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Up to 1 year
Participants receive the study drug GLB-001 orally according to the assigned treatment schedule during dose escalation, exploration, and expansion phases to evaluate safety, tolerability, and efficacy.
Visits occur regularly during dosing; exact frequency depends on study phase and dose escalation schedule
Duration - Up to 3 years
Participants are monitored for up to 3 years after treatment to assess adverse events, response to treatment, and long-term safety.
Periodic follow-up visits during the monitoring period
Trial Site Locations
Total: 14 locations
1
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China, 230001
Actively Recruiting
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
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3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
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4
The First Hospital of Hebei Medical Universtiy
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
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6
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
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7
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
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8
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
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9
Sheng Jing Hospital of China Medical Universtiy
Shenyang, Liaoning, China, 110004
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10
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
11
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
12
The Second Hospital of Tianjin Medical Universtiy
Tianjin, Tianjin Municipality, China, 300211
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13
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
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14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
J
Jing Liu, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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