Trial Title:
A Study of GLB-001 in Patients With Myeloid Malignancies
NCT ID:
NCT06378437
Condition:
Polycythemia Vera
Essential Thrombocythemia
Myelofibrosis
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Myeloid Malignancy
Conditions: Official terms:
Neoplasms
Polycythemia Vera
Myelodysplastic Syndromes
Polycythemia
Thrombocytosis
Thrombocythemia, Essential
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GLB-001
Description:
Administered orally according to the assigned treatment schedule
Arm group label:
Dose Escalation of GLB-001 in Study Participants with PV and ET-Phase 1a
Arm group label:
Dose Expansion of GLB-001 in Study Participants with PV, ET, MF, LR-MDS, AML and HR-MDS-Phase 1c
Arm group label:
Dose Exploration of GLB-001 in Study Participants with MF, LR-MDS, AML and HR-MDS-Phase 1b
Other name:
GLB-C183-A-2
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.
Criteria for eligibility:
Criteria:
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.
- QT interval interval > 470 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Address:
City:
Hefei
Zip:
230001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiaoyu Zhu, MD
Phone:
86-0551-62283160
Facility:
Name:
China-Japan Friendship Hospital
Address:
City:
Beijing
Zip:
100029
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenling Li, MD
Phone:
86-010-84205566
Facility:
Name:
The First Hospital of Hebei Medical Universtiy
Address:
City:
Shijia Zhuang
Zip:
050000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingchi Liu, MD
Phone:
86-0311-85917000
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Hu Zhou, MD
Phone:
86-0371-65587320
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuelan Zuo, MD
Phone:
86-027-67812888
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Miao Miao, MD
Phone:
86-0512-65223637
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Li, MD
Phone:
86-0791-88603000
Facility:
Name:
Sheng Jing Hospital of China Medical Universtiy
Address:
City:
Shenyang
Zip:
110004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wei Yang, MD
Phone:
86-024-96615
Facility:
Name:
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Zhang, MD
Phone:
86-022-23909240
Facility:
Name:
The Second Hospital of Tianjin Medical Universtiy
Address:
City:
Tianjin
Zip:
300211
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Bai, MD
Phone:
86-022-88328832
Facility:
Name:
The First Affilicated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongyan Tong, MD
Phone:
86-0571-87236114
Start date:
May 24, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Hangzhou GluBio Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Hangzhou GluBio Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378437
