Actively Recruiting
A Study 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
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of GLB-001 in Patients With Myeloid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must understand and voluntarily sign an informed consent form before any study procedures.
- Participants must be 18 years of age or older at consent.
- Participants must have a confirmed diagnosis of relapsed, refractory, or intolerant myeloid malignancies including polycythemia vera, essential thrombocythemia, primary myelofibrosis, myelodysplastic syndromes, or acute myeloid leukemia according to established criteria.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Participants must have a life expectancy greater than 3 months.
- Participants must have good function of major organs including blood, liver, kidney, and coagulation.
- Participants must be willing and able to adhere to the study visit schedule and other protocol requirements.
You will not qualify if you...
- Participants with acute promyelocytic leukemia (APL).
- Participants with recent treatments: for polycythemia vera or essential thrombocythemia, hydroxyurea within 2 days or other treatments within 7 days before first dose; for myelofibrosis, any treatment within 14 days before first dose; for lower-risk myelodysplastic syndrome, any treatment within 14 days before first dose; for higher-risk myelodysplastic syndrome or acute myeloid leukemia, CAR-T or biologic therapy within 28 days or other anticancer therapies within 14 days before first dose.
- Participants who received other investigational drugs within 28 days or 5 half-lives before first dose.
- Participants with unresolved significant non-blood toxicities at Grade 1 or higher, except hair loss or skin color changes.
- Participants scheduled to receive other anticancer or investigational treatments during the study.
- Participants with active graft versus host disease requiring systemic immunosuppressive therapy.
- Participants with recent stem cell transplantation within 3 months (autologous) or 6 months (allogeneic) before first dose.
- Participants with active central nervous system involvement.
- Participants with peripheral neuropathy Grade 2 or higher.
- Participants with recent or active other malignancies within 5 years, except certain in situ cancers.
- Participants with prolonged QT interval over 450 ms on screening ECG.
- Participants with impaired heart function or significant heart disease currently or within last 6 months.
- Participants with active hepatitis B or C infection.
- Participants with HIV infection.
- Participants with uncontrolled active systemic infections unrelated to blood cancers.
- Participants with conditions affecting drug absorption or metabolism as judged by investigator.
- Participants using medications or supplements strongly affecting certain liver enzymes within 7 days or 5 half-lives before first dose.
- Participants who had major surgery within 28 days before first dose or have not recovered from surgery effects.
- Pregnant or breastfeeding women.
- Participants with cognitive impairments affecting understanding or compliance.
- Participants deemed unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Actively Recruiting
3
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Actively Recruiting
4
The First Hospital of Hebei Medical Universtiy
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
5
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
6
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
7
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
8
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
9
Sheng Jing Hospital of China Medical Universtiy
Shenyang, Liaoning, China, 110004
Actively Recruiting
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
Actively Recruiting
13
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
14
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
Research Team
J
Jing Liu, Ph.D.
CONTACT
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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