Non-small Cell Lung CancerPhase 1NCT04175158
Clinical Trial in Chinese Healthy Volunteers of GB222
A Phase 1 study testing GB222 and Bevacizumab in people with Non-small Cell Lung Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- GB222 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 24 Apr 2017to Nov 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
- Subjects who voluntarily participated in the clinical study and sign the informed consent form;
- Healthy male adult volunteers aged 18 to 45 years;
- The subjects have qualified physical examination within 28 30 days before the study, the body mass index (BMI) is within the range of 19.0~24.0, 50kg for males³ and 45kg for females³, the body weight of males and females is not more than 75kg (inclusive);
- The subjects agree and adopt reliable contraceptive methods to ensure that they have no pregnancy plain from the beginning of the study to 6 months after the end of this study;
- Based on physical examination, medical history, vital signs, electrocardiogram, etc., the researchers determined that the body condition of participant was good;
- The subjects can well communicate with the investigators and complete the study as required by the study.
Exclusions:
- Allergic constitution; known allergic to the components of the investigational product or allergy history to any drug or food or pollen; subjects who have abnormal serum immunoglobulin E (IgE);
- Any current signs and symptoms or abnormalities in laboratory tests may indicate acute or subacute infection (fever, cough, urination, pain, abdominal pain, diarrhea, skin infection, wound, etc.)
- History of drug addiction or drug abuse; subjects with positive urine drug screening;
- Clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or other significant diseases; medical history of hypertension or screening systolic blood pressure³ of 140mmHg and/or diastolic blood pressure³ of 90mmHg,which are clinically significant at the discretion of the investigators;
- People with malignant tumors;
- Participated in other clinical studies within 3 months before enrollment, or subjects who received drugs which are known to injure the major organs within 3 months before enrollment;
- Blood donation within 3 months before enrollment;
- Surgery operation within 3 months before enrollment;
- Use of prescription drugs or non-prescription drugs within 14 days before enrollment;
- ALT or AST>1.5 ULN, Cr>ULN;
- Hematology test: WBC<3.0×10 9 /L or > 9.5×10 9 /L; ANC < 1.5×10 9 /L; PLT<100×10 9/L; HGB<104 g/L,conform to any of these items;
- Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);
- Subjects who have positive anti-drug antibody (ADA);
- Positive tumor marker (CEA、AFP、PSA、CA-125);
- Abnormal coagulation function, which is judged by the researcher to be clinically significant;
- Patients with a previous history of digestive tract ulcer, cerebrovascular accident, vascular lesions, etc., currently have open wounds of skin and mucosa. The researchers considered that other volunteers with risk of bleeding or coagulation should not be included in the study
- Patients with a history of mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Hospital of Peking University
Beijing, Beijing Municipality, 100034
Yi Fang, Master, 010-66583834, fygk7000@163.com
About this study
Official title: A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.
The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- GB222, Bevacizumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB222Biological
Also called Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection
Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.
BevacizumabBiological
Also called Avastin
Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.
| Study group | Role | What they receive |
|---|---|---|
| GB222 | Experimental | 1mg/kg Receives: Biological: GB222 |
| Bevacizumab | Active comparator | 1mg/kg Receives: Biological: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0- t
AUC 0- t
Measured: Up to 84 days
Secondary outcomes (3)
Cmax
Cmax
Measured: Up to 84 days
AUC0-∞
AUC0-∞
Measured: Up to 84 days
ADA
ADA
Measured: Up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start24 Apr 2017
- Primary completionAug 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yi Fang, Master, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175158
- Sponsor's protocol ID
- GENOR GB222-001; V1.3
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-controlled Comparative Study to Evaluate the PK Pharmacokinetic Similarity After Single Administration of GB222 and Bevacizumab in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04175158
- Acronym / sponsor ID
- GENOR GB222-001; V1.3
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 22 Nov 2019 (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.
The primary objective of this study is to evaluate the similarity of the primary pharmacokinetic (PK) parameter AUC0-t of GB222 and bevacizumab after single administration; the secondary objective is to observe the safety and similarities and safety of other pharmacokinetic (PK) parameters (Cmax, AUC0-∞ etc.) and immunogenicity of GB222 and bevacizumab after single administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB222 | Experimental | Biological: GB2221mg/kg |
| Bevacizumab | Active comparator | Biological: Bevacizumab1mg/kg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| GB222Also: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injectionRecombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time. | Biological | GB222 |
| BevacizumabAlso: AvastinInjection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time. | Biological | Bevacizumab |
Primary outcome
AUC 0- t
Time frame: Up to 84 days
AUC 0- t
3 secondary outcomes
Cmax
Time frame: Up to 84 days
AUC0-∞
Time frame: Up to 84 days
ADA
Time frame: Up to 84 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yi Fang, Master principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB222 and Bevacizumab in people with Non-small Cell Lung Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Yu, Master (18600332657, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC 0- t (time frame: Up to 84 days). 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 22 Nov 2019.