Polycythemia VeraPhase 1NCT06378437
A Study of GLB-001 in Patients With Myeloid Malignancies
A Phase 1 study testing GLB-001 in people with Polycythemia Vera and Essential Thrombocythemia, run by Hangzhou GluBio Pharmaceutical Co., Ltd. at 14 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis
- What is being tested?
- GLB-001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 14 sitesChina
- Study dates
- 24 May 2024to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhenling Li, MD, 86-010-84205566
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Li Wang, MD, 86-023-68811360
- Recruiting
The First Affilicated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Hongyan Tong, MD, 86-0571-87236114
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, 230001
Xiaoyu Zhu, MD, 86-0551-62283160
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
Fei Li, MD, 86-0791-88603000
- Recruiting
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Wei Wang, MD, 86-021-52889999
Guoying Cao, MD
- Recruiting
Sheng Jing Hospital of China Medical Universtiy
Shenyang, Liaoning, 110004
Wei Yang, MD, 86-024-96615
- Recruiting
The First Hospital of Hebei Medical Universtiy
Shijiazhuang, Hebei, 050000
Qingchi Liu, MD, 86-0311-85917000
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Miao Miao, MD, 86-0512-65223637
- Recruiting
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Lei Zhang, MD, 86-022-23909240
- Recruiting
The Second Hospital of Tianjin Medical Universtiy
Tianjin, Tianjin Municipality, 300211
Jie Bai, MD, 86-022-88328832
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Songfu Jiang, MD, 86-0577-55578532
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Xuelan Zuo, MD, 86-027-67812888
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Hu Zhou, MD, 86-0371-65587320
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies
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
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis, Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myeloid Malignancy
- Being tested
- GLB-001
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Primary Myelofibrosis, Myelodysplastic Syndromes, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLB-001Drug
Also called GLB-C183-A-2
Administered orally according to the assigned treatment schedule
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of GLB-001 in Study Participants with PV and ET-Phase 1a | Experimental | Phase 1a (Dose Escalation) will evaluate the safety and tolerability of GLB-001 in PV and ET study participants. A standard 3+3 dose-escalation design will be applied to evaluate a set of dose levels to determine and the maximum tolerated dose (MTD) and/or recommended expansion doses (RED) in PV and ET study participants who are eligible for dose limiting toxicity (DLT) evaluation. Receives: Drug: GLB-001 |
| Dose Exploration of GLB-001 in Study Participants with MF, LR-MDS, AML and HR-MDS-Phase 1b | Experimental | Phase Ib 1b (Dose Exploration) will utilize a standard 3+3 dose-escalation design to evaluate the safety and tolerability of GLB-001 in MF, LR-MDS, HR-MDS and AML study participants. The starting dose will be selected within the range of tolerated dose levels determined in Phase 1a (Dose escalation). Receives: Drug: GLB-001 |
| Dose Expansion of GLB-001 in Study Participants with PV, ET, MF, LR-MDS, AML and HR-MDS-Phase 1c | Experimental | Phase 1c (Dose Expansion) will be conducted to further determine the tolerability, efficacy and the recommended phase 2 dose (RP2D) of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including PV, ET, MF, LR-MDS, HR-MDS and AML. Receives: Drug: GLB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
DLT is defined as the treatment emergent adverse events (TEAEs) meeting protocol specified DLT criteria and occurring within the DLT assessment period.
Measured: Up to 28 days after first dose of study treatment in Phase 1a and Phase 1b
Maximum Tolerated Dose (MTD)
MTD is defined as the highest dose level at which no more than 1 of 6 DLT-evaluable study participants experienced a DLT.
Measured: Up to 1 year in Phase 1a and Phase 1b
Recommended Expansion Doses (RED)
RED will be determined by the safety review committee (SRC) according to the safety, tolerability, PK, PD, and preliminary efficacy of GLB-001 in dose escalation phase and dose exploration phase.
Measured: Up to 1 year in Phase 1a and Phase 1b
Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs)
AE is any untoward medical occurrence in a study participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AE will be graded according to the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) version 5.0.
Measured: Up to 3 years in Phase 1a and Phase 1b
Recommended Phase 2 Dose (RP2D)
RP2D based on the totality of data across dosing cohorts in the dose escalation, dose exploration and dose expansion phases of the study including PK, PD, safety and efficacy outcomes.
Measured: Up to 1 year in Phase 1c
Response Assessment in Study Participants With PV
Response will be evaluated according to the European Leukemia Net (ELN) and 2013 International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria, including overall response rate (ORR), duration of remission or response (DOR), time to response (TTR), progression-free survival (PFS), percentage of study participants who achieved complete hematologic response (CHR), duration of CHR, percentage of study participants with hematocrit (HCT) <45%, percentage of study participants with >50% change in Myeloproliferative Neoplasm Symptom Assessment Total Symptom Score (MPN-SAF TSS), percentage of study participants who achieve spleen volume reduction of greater than or equal to 35% (SVR35) from baseline, duration of SVR35 (DoMSR), change from baseline of JAK2 mutated allele burden.
Measured: Up to 3 year in Phase 1c
Response Assessment in Study Participants With ET
Response will be evaluated according to ELN and 2013 IWG-MRT criteria, including ORR, DOR, TTR, PFS, percentage of study participants who achieved CHR, duration of CHR, percentage of study participants with >50% change in MPN-SAF TSS, percentage of study participants who achieve SVR35 from baseline, DoMSR, change from baseline of JAK2 mutated allele burden.
Measured: Up to 1 year in Phase 1c
Response Assessment in Study Participants With MF
Response will be evaluated according to the European Myelofibrosis Network (EUMNET) and 2013 IWG-MRT criteria, including ORR, DOR, TTR, PFS, percentage of study participants who achieve anemia response, percentage of study participants with symptom response, percentage of study participants who achieve SVR35 from baseline, DoMSR, change from baseline of JAK2 mutated allele burden.
Measured: Up to 1 year in Phase 1c
Response Assessment in Study Participants With LR-MDS
Response will be evaluated according to the 2006 Myelodysplastic Syndromes International Council for Harmonisation (MDS-IWG) criteria, including percentage of study participants with hematology improvement (HI) (erythroid/platelet/neutrophil responses), percentage of study participants with complete response (CR), partial response (PR) or marrow complete response (mCR), DOR, TTR, PFS, percentage of study participants who achieve red blood cell transfusion independence (RBC-TI) ≥ 8 weeks, time to RBC-TI and duration of RBC-TI for study participants who achieve RBC TI ≥ 8 weeks on treatment.
Measured: Up to 1 year in Phase 1c
Response Assessment in Study Participants With HR-MDS
Response was evaluated according to the 2006 MDS-IWG criteria, including HI (erythroid/platelet/neutrophil responses), percentage of study participants with CR, PR or mCR, DOR, TTR, PFS, minimal residual disease (MRD) monitoring in participants who achieve CR.
Measured: Up to 1 year in Phase 1c
Response Assessment in Study Participants With AML
Response was evaluated according to the 2022 ELN for AML criteria, including CR, CR with incomplete hematologic recovery (CRi), CR with partial hematological recovery (CRh), morphologic leukemia-free state (MLFS), percentage of study participants with PR, DOR, TTR, event-free survival (EFS), MRD monitoring in study participants who achieve CR/CRi/CRh.
Measured: Up to 1 year in Phase 1c
Secondary outcomes (22)
GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last
Area under the concentration-time curve from zero to the last measurable concentration.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24
Area under the concentration-time curve from 0 to 24 hours.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf
Area under the concentration-time curve from 0 to infinity.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax
Maximum plasma concentration.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax
The time to reach maximum concentration.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2
Terminal half-life.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F
Apparent volume of distribution.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F
Apparent total clearance of the drug from plasma after oral administration.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz
Terminal rate constant.
Measured: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss
Time of maximum concentration at steady state.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss
Average plasma concentration at steady state.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss
Maximum plasma concentration at steady state.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss
Minimum plasma concentration at steady state.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau
Area under the concentration-time curve during the dosing interval.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last
Area under the concentration-time curve from zero to the last measurable concentration.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz
Terminal rate constant.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F
Apparent volume of distribution.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F
Apparent clearance at steady state.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2
Terminal half-life.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC]
Accumulation index in area under the concentration-time curve.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax]
Accumulation index in maximum plasma concentration.
Measured: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF
Degree of fluctuation index.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start24 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou GluBio Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Lu, Ph.D., Study director, Hangzhou GluBio Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378437
- Sponsor's protocol ID
- GLB-001-02
- Status last verified
- Mar 2025
- First submitted
- 18 Apr 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-001 in Patients With Myeloid Malignancies
- ClinicalTrials.gov ID
- NCT06378437
- Acronym / sponsor ID
- GLB-001-02
- Conditions
- Polycythemia Vera, Essential Thrombocythemia, Myelofibrosis, Myelodysplastic Syndromes, Acute Myeloid Leukemia, Myeloid Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hangzhou GluBio Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of GLB-001 in Study Participants with PV and ET-Phase 1a | Experimental | Drug: GLB-001Phase 1a (Dose Escalation) will evaluate the safety and tolerability of GLB-001 in PV and ET study participants. A standard 3+3 dose-escalation design will be applied to evaluate a set of dose levels to determine and the maximum tolerated dose (MTD) and/or recommended expansion doses (RED) in PV and ET study participants who are eligible for dose limiting toxicity (DLT) evaluation. |
| Dose Exploration of GLB-001 in Study Participants with MF, LR-MDS, AML and HR-MDS-Phase 1b | Experimental | Drug: GLB-001Phase Ib 1b (Dose Exploration) will utilize a standard 3+3 dose-escalation design to evaluate the safety and tolerability of GLB-001 in MF, LR-MDS, HR-MDS and AML study participants. The starting dose will be selected within the range of tolerated dose levels determined in Phase 1a (Dose escalation). |
| Dose Expansion of GLB-001 in Study Participants with PV, ET, MF, LR-MDS, AML and HR-MDS-Phase 1c | Experimental | Drug: GLB-001Phase 1c (Dose Expansion) will be conducted to further determine the tolerability, efficacy and the recommended phase 2 dose (RP2D) of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including PV, ET, MF, LR-MDS, HR-MDS and AML. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLB-001Also: GLB-C183-A-2Administered orally according to the assigned treatment schedule | Drug | Dose Escalation of GLB-001 in Study Participants with PV and ET-Phase 1a, Dose Expansion of GLB-001 in Study Participants with PV, ET, MF, LR-MDS, AML and HR-MDS-Phase 1c, Dose Exploration of GLB-001 in Study Participants with MF, LR-MDS, AML and HR-MDS-Phase 1b |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: Up to 28 days after first dose of study treatment in Phase 1a and Phase 1b
DLT is defined as the treatment emergent adverse events (TEAEs) meeting protocol specified DLT criteria and occurring within the DLT assessment period.
Maximum Tolerated Dose (MTD)
Time frame: Up to 1 year in Phase 1a and Phase 1b
MTD is defined as the highest dose level at which no more than 1 of 6 DLT-evaluable study participants experienced a DLT.
Recommended Expansion Doses (RED)
Time frame: Up to 1 year in Phase 1a and Phase 1b
RED will be determined by the safety review committee (SRC) according to the safety, tolerability, PK, PD, and preliminary efficacy of GLB-001 in dose escalation phase and dose exploration phase.
Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs)
Time frame: Up to 3 years in Phase 1a and Phase 1b
AE is any untoward medical occurrence in a study participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. AE will be graded according to the National Cancer Institute Common Terminology Criteria for AE (NCI CTCAE) version 5.0.
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 1 year in Phase 1c
RP2D based on the totality of data across dosing cohorts in the dose escalation, dose exploration and dose expansion phases of the study including PK, PD, safety and efficacy outcomes.
Response Assessment in Study Participants With PV
Time frame: Up to 3 year in Phase 1c
Response will be evaluated according to the European Leukemia Net (ELN) and 2013 International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria, including overall response rate (ORR), duration of remission or response (DOR), time to response (TTR), progression-free survival (PFS), percentage of study participants who achieved complete hematologic response (CHR), duration of CHR, percentage of study participants with hematocrit (HCT) <45%, percentage of study participants with >50% change in Myeloproliferative Neoplasm Symptom Assessment Total Symptom Score (MPN-SAF TSS), percentage of study participants who achieve spleen volume reduction of greater than or equal to 35% (SVR35) from baseline, duration of SVR35 (DoMSR), change from baseline of JAK2 mutated allele burden.
Response Assessment in Study Participants With ET
Time frame: Up to 1 year in Phase 1c
Response will be evaluated according to ELN and 2013 IWG-MRT criteria, including ORR, DOR, TTR, PFS, percentage of study participants who achieved CHR, duration of CHR, percentage of study participants with >50% change in MPN-SAF TSS, percentage of study participants who achieve SVR35 from baseline, DoMSR, change from baseline of JAK2 mutated allele burden.
Response Assessment in Study Participants With MF
Time frame: Up to 1 year in Phase 1c
Response will be evaluated according to the European Myelofibrosis Network (EUMNET) and 2013 IWG-MRT criteria, including ORR, DOR, TTR, PFS, percentage of study participants who achieve anemia response, percentage of study participants with symptom response, percentage of study participants who achieve SVR35 from baseline, DoMSR, change from baseline of JAK2 mutated allele burden.
Response Assessment in Study Participants With LR-MDS
Time frame: Up to 1 year in Phase 1c
Response will be evaluated according to the 2006 Myelodysplastic Syndromes International Council for Harmonisation (MDS-IWG) criteria, including percentage of study participants with hematology improvement (HI) (erythroid/platelet/neutrophil responses), percentage of study participants with complete response (CR), partial response (PR) or marrow complete response (mCR), DOR, TTR, PFS, percentage of study participants who achieve red blood cell transfusion independence (RBC-TI) ≥ 8 weeks, time to RBC-TI and duration of RBC-TI for study participants who achieve RBC TI ≥ 8 weeks on treatment.
Response Assessment in Study Participants With HR-MDS
Time frame: Up to 1 year in Phase 1c
Response was evaluated according to the 2006 MDS-IWG criteria, including HI (erythroid/platelet/neutrophil responses), percentage of study participants with CR, PR or mCR, DOR, TTR, PFS, minimal residual disease (MRD) monitoring in participants who achieve CR.
Response Assessment in Study Participants With AML
Time frame: Up to 1 year in Phase 1c
Response was evaluated according to the 2022 ELN for AML criteria, including CR, CR with incomplete hematologic recovery (CRi), CR with partial hematological recovery (CRh), morphologic leukemia-free state (MLFS), percentage of study participants with PR, DOR, TTR, event-free survival (EFS), MRD monitoring in study participants who achieve CR/CRi/CRh.
22 secondary outcomes
GLB-001 and GLB-C183-A-2 (diastereoisomer of GLB-001) Pharmacokinetics after Single Administration - AUC0-last
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-24
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - AUC0-inf
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Cmax
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Tmax
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - T1/2
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - Vz/F
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - CL/F
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Single Administration - λz
Time frame: Up to 48 hours after single administration
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Tmax,ss
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cav,ss
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmax,ss
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Cmin,ss
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - AUC0-tau
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-AUC0-last
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - λz
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Vz/F
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - CLss/F
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - T1/2
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [AUC]
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration - Rac [Cmax]
Time frame: Up to 1 year
GLB-001 and GLB-C183-A-2 Pharmacokinetics after Multiple Administration-DF
Time frame: Up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gang Lu, Ph.D. study director
Hangzhou GluBio Pharmaceutical Co., Ltd.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLB-001 in people with Polycythemia Vera and Essential Thrombocythemia, run by Hangzhou GluBio Pharmaceutical Co., Ltd. at 14 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Liu, Ph.D. (86-18616699599, Jing.Liu@glubiotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity (DLT) (time frame: Up to 28 days after first dose of study treatment in Phase 1a and Phase 1b). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.