Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06219356
Other study ID # GLB-002-01
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 11, 2024
Est. completion date February 28, 2027

Study information

Verified date April 2024
Source Hangzhou GluBio Pharmaceutical Co., Ltd.
Contact Jing Liu, MD
Phone 86-18616699599
Email Jing.Liu@glubiotx.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date February 28, 2027
Est. primary completion date January 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Receipt of anticancer medications/therapies such as chemotherapy, targeted therapy, immunotherapy, biologic therapy, or herbal agent = 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002; or chimeric antigen receptor T cell therapy (CAR-T) within 3 months prior to the first dose of GLB-002. - Currently enrolled in any other investigational drug study or participation within the last 28 days or 5 half-lives, whichever is shorter, prior to the first dose of GLB-002 (exception of participants who participated in only one investigational drug study with overall survival follow-up). - Participants with unresolved clinically significant toxicities of > Grade 1 AE or not be recovered to baseline value from prior anticancer therapies with exception of alopecia or hyperpigmentation of the skin. - Participants who are scheduled to receive other anticancer therapies or other investigational drugs during the study period. - Participants with active acute or chronic graft versus host disease (GVHD) requiring systemic immunosuppressive therapy (except corticosteroids at a dose equivalent to 12 mg or less of prednisone per day). - Receipt of Autologous Stem Cell Transplantation (ASCT) within the last 3 months, or allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-002. - Participants with known active leukemic involvement in central nervous system (CNS). - Participants with peripheral neuropathy = Grade 2 (Graded according to CTCAE version 5.0). - History of, or current active cancer other malignancy 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. - Participants has impaired cardiac function or clinically significant cardiac disease at current or within last 6 months. - Participants with known active infection of hepatitis B virus (HBV) or hepatitis C virus C (HCV). - Participants with known human immunodeficiency virus (HIV) infection. - Participants with known life-threatening or clinical significant uncontrolled active systemic infections unrelated to malignant hematologic diseases - Participants with a condition that may affects the absorption, distribution, metabolism and excretion of GLB-002. - Medications or supplements that are known to be strong and moderate inhibitors or inducers of cytochrome P-450 isozyme (CYP)3A4/5 and/or P-glycoprotein (P-gp) within 7 days or 5 half-lives prior to the first dose of GLB-002, whichever is shorter. - Participants who have undergone major surgery within 28 days prior to the first dose of the GLB-002. - Pregnant or lactating women. - 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. - Participants,in the opinion of the Investigator, who are unsuitable to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
GLB-002
Administered orally according to the assigned treatment schedule.

Locations

Country Name City State
China Beijing Cancer Hospital Beijing Beijing
China Sun Yat-Sen University Cancer Center Guangzhou Guangdong
China The First Affilicated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang
China Jiangxi Cancer Hospital Nanchang Jiangxi
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China Tianjing Medical University Cancer Institute and Hospital Tianjin Tianjin
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Hangzhou GluBio Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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, except those that are clearly and incontrovertibly due to extraneous causes including disease progression, pre-existing medical condition that has not worsened from baseline, or other causes that are clearly not due to study drug. Up to 35 days after first dose of study treatment in Phase 1a
Primary Maximum Tolerated Dose (MTD) MTD is defined as the highest dose level at which no more than 1 of 6 DLT-evaluable participants experienced a DLT. Up to 2 years (each cycle is 28 days)
Primary Recommended Expansion Doses (RED) RED will be decided by safety review committee (SRC) considering the data including safety, tolerability, PK, PD, and preliminary efficacy of GLB-002 in dose escalation. RED will be the dose level below MTD. Up to 2 years (each cycle is 28 days)
Primary Incidence, Relatedness, Seriousness and Severity of Adverse Events (AEs) AE is any untoward medical occurrence in a 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. Up to 2 years
Primary Recommended Phase 2 Dose (RP2D) RP2D based on the totality of data across dosing cohorts in the dose escalation and expansion phases of the study including PK, PD, safety and efficacy outcomes. Up to 2 years
Primary Objective Response Rate (ORR) ORR is defined as the percent of participants whose best overall response is complete response (CR) or partial response (PR). CR and PR will be assessed by 2014 Lugano for NHL and/or 2018 International Working Group Criteria for Chronic Lymphocyte Leukemia (2018 IWCLL). Up to 2 years
Primary Time to Response (TTR) For participants with objective response, TTR was defined as the time of participants from the first treatment administration to the first incidence of a confirmed CR or PR was reported. CR and PR will be assessed by 2014 Lugano for NHL and/or 2018 IWCLL. Up to 2 years
Primary Duration of Remission or Response (DOR) For participants with objective response, DOR is measured from the time of any of CR or PR are first met (whichever is first recorded) until the first date at which progressive disease or death from any cause is objectively documented assessment. CR and PR will be assessed by 2014 Lugano for NHL and/or 2018 IWCLL. Up to 2 years
Primary Progression-free Survival (PFS) PFS is defined as the time from the first dose of GLB-002 to the first occurrence of progressive disease (PD) or death from any cause. PD will be assessed by 2014 Lugano for NHL and/or 2018 IWCLL. Up to 2 years
Primary Overall Survival (OS) OS is defined as the time from the first dose of GLB-002 to death due to any cause. Up to 2 years
Secondary GLB-002 and GLB-A062-A (R-enantiomers of GLB-002) Pharmacokinetics after Single Administration-AUC0-last Area under the concentration-time curve from zero to the last measurable concentration Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-AUC0-24 Area under the concentration-time curve from 0 to 24 hours Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-AUC0-inf Area under the concentration-time curve from 0 to infinity Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-Cmax Maximum plasma concentration Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-Tmax The time to reach maximum concentration Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-T1/2 Terminal half-life Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-Vz/F Apparent volume of distribution Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-CL/F Apparent total clearance of the drug from plasma after oral administration Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Single Administration-?z Terminal rate constant Up to 48 hours after single administration
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Tmax,SS Time of maximum concentration at steady state Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Cav,SS Average plasma concentration at steady state Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Cmax,SS Maximum plasma concentration at steady state Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Cmin,SS Minimum plasma concentration at steady state Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-AUC0-tau Area under the concentration-time curve during the dosing interval Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-?z Terminal rate constant Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Vz/F Apparent volume of distribution Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-CLSS/F Apparent clearance at steady state Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-T1/2 Terminal half-life Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Rac [AUC] Accumulation index in area under the concentration-time curve Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-Rac [Cmax] Accumulation index in maximum plasma concentration Up to 2 years
Secondary GLB-002 and GLB-A062-A Pharmacokinetics after Multiple Administration-DF Degree of fluctuation index Up to 2 years
See also
  Status Clinical Trial Phase
Completed NCT01947140 - Pralatrexate + Romidepsin in Relapsed/Refractory Lymphoid Malignancies Phase 1/Phase 2
Active, not recruiting NCT03755414 - Study of Itacitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation Phase 1
Recruiting NCT05019976 - Radiation Dose Study for Relapsed/Refractory Hodgkin/Non-Hodgkin Lymphoma N/A
Active, not recruiting NCT04082936 - A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT01527045 - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Phase 2
Completed NCT04666025 - SARS-CoV-2 Donor-Recipient Immunity Transfer
Recruiting NCT06018129 - A First-in-human Trial of GEN3017 in Hodgkin Lymphoma and Non-Hodgkin Lymphoma Phase 1/Phase 2
Completed NCT02543879 - Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies Phase 1
Completed NCT01939327 - Safety and Efficacy of Revlimid® (Lenalidomide) With Mabthera® (Rituximab) in Non-Hodgkin's Lymphoma Phase 2
Completed NCT00503451 - A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors Phase 1
Completed NCT01010295 - A Clinico-Pathological Study to Investigate the Possible Infective Causes of Non-Hodgkin Lymphoma of the Ocular Adnexae Phase 2
Terminated NCT00383097 - Lmp1 and Lmp2 Specific CTLs Following Cd45 Antibody for Relapsed Ebv-Positive Hodgkin's Or Non-Hodgkin's Lymphoma Phase 1
Completed NCT00509379 - Non-randomized Safety Study With Bortezomib/Rituximab in Relapsed/Refractory Indolent Lymphoma Phase 2
Completed NCT00992446 - Bortezomib and Vorinostat as Maintenance Therapy After Autologous Stem Cell Transplant in Treating Patients With Non-Hodgkin Lymphoma Phase 2
Recruiting NCT05066958 - Ex-vivo Primed Memory Donor Lymphocyte Infusion to Boost Anti-viral Immunity After T-cell Depleted HSCT Phase 1/Phase 2
Active, not recruiting NCT05205512 - Telehealth Exercise Intervention to Improve Cardiovascular Health in Lymphoma Survivors, TECHS Trial N/A
Recruiting NCT05006716 - A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies Phase 1/Phase 2
Completed NCT03297424 - A Study of PLX2853 in Advanced Malignancies. Phase 1
Completed NCT02767388 - Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery
Active, not recruiting NCT03997968 - A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors Phase 1/Phase 2