Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma
GB226
With Open, Single/Multiple Dosing and Dose Escalation, Phase I Clinical Trial Scheme to Evaluate Safety, Tolerance and Pharmacokinetic Properties of Genolimzumab Injection
1 other identifier
interventional
72
1 country
2
Brief Summary
With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in Chinese patients of advanced and (or) recurrent solid tumor/lymphoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2017
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 19, 2017
CompletedFirst Submitted
Initial submission to the registry
December 6, 2017
CompletedFirst Posted
Study publicly available on registry
December 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedAugust 16, 2021
March 1, 2021
4.6 years
December 6, 2017
August 12, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
adverse event
adverse event
all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Serious Adverse Event
Serious Adverse Event
all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Dose limiting Toxicity, DLT
Dose limiting Toxicity, DLT
Day 1 to Day 28 after first dose
Maximum Tolerated Dose, MTD
Maximum Tolerated Dose, MTD
Day 1 to Day 28 after first dose
Secondary Outcomes (11)
AUC 0-t
up to 12 weeks
C max
up to 12 weeks
AUC 0-∞
up to 12 weeks
T max
up to 12 weeks
Vd
up to 12 weeks
- +6 more secondary outcomes
Study Arms (8)
GB226 1mg/kg single-dose
EXPERIMENTALGeptanolimab, 1mg/kg, i.v., single-dose
GB226 3 mg/kg single-dose
EXPERIMENTALGeptanolimab, 3mg/kg, i.v., single-dose
GB226 10mg/kg single-dose
EXPERIMENTALGeptanolimab 10mg/kg, i.v., single-dose
GB226 1mg/kg multiple dosing, every 2 weeks
EXPERIMENTALGeptanolimab, 1mg/kg, i.v., q2w\*6
GB226 3mg/kg multiple dosing,every 2 weeks
EXPERIMENTALGeptanolimab, 3mg/kg, i.v., q2w\*6
GB226 10mg/kg multiple dosing, every 2 weeks
EXPERIMENTALGeptanolimab,10mg/kg, i.v., q2w\*6
GB226 280mg multiple dosing
EXPERIMENTALGeptanolimab, 280mg, i.v., q3w
GB226 3mg/kg multiple dosing
EXPERIMENTALGeptanolimab, 3mg/kg, i.v., q2w
Interventions
single-dose:1mg/kg
single-dose: 3mg/kg
single-dose:10mg/kg
multiple dosing: 1mg/kg, q2w\*6
multiple dosing: 3mg/kg, q2w\*6
multiple dosing: 10mg/kg, , q2w\*6
multiple dosing: 280mg, q3w
multiple dosing: 3mg/kg, q2w
Eligibility Criteria
You may qualify if:
- \. Age: 18-65. Unisex.
- \. Understand trial procedure and content and sign informed consent voluntarily;
- \. Patients of advanced (phase Ⅲb, multidisciplinary treatment is not appropriate), metastatic (phase IV) or recurrent solid tumor (including melanoma, NSCLC, renal cell carcinoma, head \& neck cancer, esophagus cancer, liver cancer, bladder cancer, spongioblastoma) or lymphoma (classical hodgkin lymphoma and (or) peripheral T-cell lymphoma, natural killer (NK)-T cell lymphoma and mediastinal B cell lymphoma) conformed by histology or cytology and cannot be cured by surgery. There is no effective standard treatment now.
- \. Agree to provide recorded tumor tissue sample or fresh tissue sample.
- \. Eastern Cooperative Oncology Group (ECOG): 0-1;
- \. Expected life ≥ 3 months;
- \. With at least one measurable and evaluable tumor (solid tumor is subject to criteria for evaluating efficacy of Immune-Related Response Criteria (irRC)/RECIST and lymphoma is subject to criteria/revised criteria of international working group);
- \. Without severe haematological, cardiopulmonary, liver and kidney diseases except protopathic. For patients of solid tumor, hemoglobin≥9g/dl, neutrophile granulocyte≥1.5×109/L, blood platelet≥100×1012/L. For patients of hematologic tumor, hemoglobin≥8g/dl, neutrophile granulocyte≥1.0×109/L, blood platelet≥80×1012/L.
- \. Serum creatinine≤1.5xUpper Limit Of Normal (ULN) or creatinine clearance rate≥50mL/min and urine protein\<2+ in test paper of urine. For patients with urine protein great than or equal to 2+ in test paper of urine, urine shall be collected in 24 hours and urine protein must less than or be equal to 1g.
- etc.
You may not qualify if:
- \. Meningeal metastases or meningeal infiltration of tumors;
- \. Patients with other malignant tumors (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) shall not participate in the research, unless he/she has been fully relieved at least 2 years without the need of other treatment or other treatment is not needed during the research.
- \. With active, known or suspected autoimmune disease.
- \. With previous usage of PD-1 antibody, PD-L1 antibody, PD-L2 antibody or cytotoxic T-lymphocyte-associated antigen-4 immunoglobulin (CTLA-4) antibody for treatment (or other antibody for co-stimulation or check point assess of T cells)
- With severe internal medicine diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, active peptic ulcer, active bleeding.
- \. With active infection.
- \. With active tuberculosis infection; with active tuberculosis infection in the past.
- \. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and treponema pallidum antibody (TP-Ab). Positive subjects of HBsAg may not be excluded from patients of liver cancer.
- \. Complication with the need of immunosuppressive drug or complication with the need of corticosteroids for whole or partial body in the dosage of immunosuppressive action.
- etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuankai Shi, Doctor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2017
First Posted
December 14, 2017
Study Start
October 19, 2017
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
August 16, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to make individual participant data available.