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A Study of GLB-001 in Patients With Myeloid Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of GLB-001 in Patients With Myeloid Malignancies

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies

NCT06378437•Hangzhou GluBio Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+11 more criteria

Locations (14)

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

Key Dates

Start Date

May 24, 2024

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2027

Last Updated

August 19, 2025

Enrollment

108

ESTIMATED participants

Conditions

Polycythemia VeraEssential ThrombocythemiaMyelofibrosisMyelodysplastic SyndromesAcute Myeloid LeukemiaMyeloid Malignancy

Interventions

GLB-001

DRUG

Contacts

Jing Liu, Ph.D.

CONTACT

86-18616699599 Jing.Liu@glubiotx.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of GLB-001 in Patients With Myeloid Malignancies

Inclusion Criteria

Exclusion Criteria

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

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