A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of GLB-002 in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL)
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
Study GLB-002-01 is a first-in-human (FIH), phase 1, open-label, dose escalation and expansion clinical study, the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-002 monotherapy in participants with relapsed or refractory Non-Hodgkin lymphomas (R/R NHL).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being performed.
• Participants is ≥18 years of age at the time of signing the ICF.
• Participants with histopathologically or immunohistochemically confirmed NHL according to 2016 World Health Organization (WHO) haematolymphoid tumors criteria classification (CLL/SLL diagnosis according to 2018 IWCLL) who have failed standard of care therapy or lack an effective treatment regimen.
• Participants in Phase Ib screening period with measurable lesion, but no measurable nodal lesion limit for participants in Phase Ia.
• 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.
• Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Hunan Cancer Hospital
RECRUITING
Changsha
Sun Yat-Sen University Cancer Center
RECRUITING
Guangzhou
The First Affilicated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Jiangxi Cancer Hospital
RECRUITING
Nanchang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
Shanxi Cancer hospital
RECRUITING
Taiyuan
Tianjing Medical University Cancer Institute and Hospital
RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
RECRUITING
Xiamen
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Jing Liu, MD
Jing.Liu@glubiotx.com
86-18616699599
Time Frame
Start Date:2024-01-11
Estimated Completion Date:2027-02-28
Participants
Target number of participants:110
Treatments
Experimental: Dose Escalation of GLB-002 in Participants with R/R NHL-Phase 1a
Part 1a (Dose Escalation) of the study will enroll R/R NHL participants and will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-002 administered orally, and determine the maximum tolerated dose (MTD) and/or recommended expansion doses (RED) in R/R NHL patients who are eligible for dose limiting toxicity (DLT) evaluation.
Experimental: Dose Expansion of GLB-002 in Participants with R/R FL (Grade 1, 2, 3a)-Phase 1b Cohort 1
Part 1b (Dose Expansion) Cohort 1 will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R Follicular Lymphoma (Grade 1、2、3a).
Experimental: Dose Expansion of GLB-002 in Participants with R/R DLBCL and FL (Grade 3b)-Phase 1b Cohort 2
Confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for R/R Diffuse Large B-cell Lymphoma and R/R Follicular Lymphoma (Grade 3b).
Experimental: Dose Expansion of GLB-002 in Participants with other R/R NHL-Phase 1b Cohort 3
Part 1b (Dose Expansion) Cohort 3 will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development for other R/R NHL, including, but not limited to Mantle-cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL), Small Lymphocytic Lymphoma (SLL) /Chronic Lymphocytic Leukemia (CLL) and Peripheral T-cell Lymphoma (PTCL).