Brain TumorPhase 1NCT04178057

Phase I Clinical Study of GB222 to Evaluate the Safety, Tolerability and PK Profiles.

A Phase 1 study testing GB222 3mg/kg, GB222 5mg/kg and GB222 7.5mg/kg in people with Brain Tumor, run by Genor Biopharma Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

This study is designed to assess the safety and tolerability, pharmacokinetic profiles, immunogenicity of GB222 in Chinese patients with relapsed/progressive high-grade glioma; moreover, changes in cerebral edema, changes in KPS score from baseline, objective response rate (ORR), 4-month progression-free survival… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Brain Tumor
What is being tested?: GB222 3mg/kg, GB222 5mg/kg and GB222 7.5mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 16 Oct 2018to Apr 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patients can be enrolled only if they meet the following all inclusion criteria:
Age ≥ 18 years, male or female;
Understand the study procedures and contents, and voluntarily sign the written informed consent form;
Histologically or cytologically confirmed advanced high-grade glioma which failed respond to conventional treatment and is unsuitable to receive multidisciplinary treatment, WHO grades III-IV;
Disease progression (recurrence) after first-line treatment including surgery, radiotherapy and temozolomide chemotherapy;
MRI confirmed tumor progression (within 14 days before the administration of investigational product);

Show all 17Show fewer

KPS score ≥50;
Life expectancy≥3 months;
The resection of relapsed brain tumors is performed at least 4 weeks before the use of investigational products, or sereotactic mamography biopsy of brain tumors is performed at least 2 weeks before the use of investigational products;
The radiotherapy is performed at least 12 weeks before the use of investigational products, unless that the size increased of relapsed tumor is larger than that of the site received radiotherapy or histologically confirmed tumor progression;
The chemotherapy is completed at least 4 weeks before the use of investigational products;
At least one measurable and evaluable tumor lesion (in accordance with RANO criteria);
Prior to the use of investigational product, all adverse reactions related to the previous treatment must recover to the level specified in the inclusion criteria, grade 0 or 1 (the following is excluded -including but not limited to alopecia, laboratory parameters in the inclusion criteria and common lymphocytopenia after temozolomide treatment);
The investigational products can be used after 5 half-lives of other previously used investigational products, after 4 weeks of cytotoxic agents (23 days for temozolomide, 6 weeks for nitrosoureas) and after 4 weeks of monoclonal antibodies (or 5 half-lives, whichever is longer);
Subjects who have no serious hematological, cardiopulmonary, hepatorenal disease, hemoglobin (Hb) ≥9g/dl, white blood cell count ≥3.5×109/L, neutrophil ≥1.5×109/L, platelet≥100×109/L; serum creatinine (Cr) ≤1.5xULN or calculated value of creatinine clearance *≥50mL/min; urine protein < 2+ or less than 1.0g/L (if urine protein in routine urine test is ≥2+ or 1.0g/L at baseline, quantitative test of 24h urinary protein shall be performed. If it is < 1g/24 hours, the subjects can be enrolled); total bilirubin < 1.0xULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5xULN; international normalized ratio (INR) ≤1.0xULN, and prothrombin time (PT) and activated partial thromboplastin time (APTT)≤1.0xULN;
Females of child-bearing potential have negative pregnancy test; males or females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study.
Patients can receive follow-up visits as scheduled, well communicate with the investigators and complete the study as required by the study. *Ccr for males=(140-age) × body weight (kg)/(72×Scr (mg/dl)); or Ccr for females=[(140-age)×body weight (kg)]/[85×Scr (mg/dl)]

Who cannot join

The subjects are not allowed to participate in this clinical study if they meet any of the following criteria:
Subjects with brain neoplasms which occur in brain stem;
Subjects with diffuse meningeal dissemination;
Subjects who previously had other malignancies (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) are not allowed to participate in the study unless he/she completely relieved at least 2 years before being enrolled in this study and requires no other treatment now or during the study period.
Subjects who have active, known or suspected autoimmune diseases;
Subjects who received treatment with systemic immunosuppressive therapies within 6 months before the use of investigational products;

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Subjects who received large dose of systemic glucocorticoids within 2 weeks before the use of investigational products, which is equivalent to dexamethasone >4.1mg/d or equivalent dose, administration for 3 continuous days[3].
Subjects who previously received isotopic radiotherapy, implanted chemotherapy, stereotactic radiotherapy or local injection or convection-enhanced delivery (CED);
The medical history or test results showing thrombotic diseases within 6 months before enrollment;
Subjects who received larger surgical procedures, experienced significant trauma, or expected to receive major surgery during the study treatment period within 4 weeks before the use of investigational products;
Subjects who received minor surgical procedures (including cannulation) within 48 hours before the use of the first monoclonal antibody and are considered to have bleeding tendency at the discretion of the investigator;
Subjects who currently or recently (within 10 days before the first dose of monoclonal antibody) used aspirin (>325mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs) which are known to inhibit platelet function;
Subjects who currently or recently (within 10 days before the first dose of monoclonal antibody) are treated with whole dose of oral or parenteral anticoagulants or thrombolytic therapies;
The medical history or test results showing hereditary bleeding tendency or coagulation disorders, thus increasing the risks of bleeding;
Patients with complicated serious internal diseases, including uncontrolled diabetes mellitus, active gastrointestinal ulcer, active bleeding etc.;
Uncontrolled hypertension (systolic blood pressure >140 mmHg and/or diastolic pressure > 90 mmHg);
Patients who previously have hypertensive crisis or hypertensive encephalopathy;
Subjects with clinical significant (e.g., active) cerebrovascular diseases, e.g., cerebrovascular accident (CVA) or transient ischemic attack (TIA) (≤6 months before enrollment), myocardial infarction (≤6 months before enrollment), unstable angina pectoris, congestive heart failure (New York Heart Association grade III or above), subjects who require drug therapies during the study period which may interfere study treatment, or subjects with serious arrhythmia which cannot be controlled by drugs;
Subjects with significant vascular diseases within 6 months before the use of investigational products (including but not limited to aortic aneurysm requiring repair surgery or recent artery thrombosis);
Subjects with non-cured wound, active peptic ulcer or fracture;
Subjects who are diagnosed with tracheoesophageal fistula;
Subjects who have medical history of abdominal fistula, gastrointestinal perforation or intraperitoneal abscess;
Subjects who have active infection (≥CTCAE grade 2);
Previously or currently suffering from active pulmonary tuberculosis (TB) infection;
Any of the following is positive: hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);
Positive hepatitis B surface antigen (HBsAg) and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) >103 copies/L, if HBV-DNA titer test <103 copies/L, and the investigator considers that chronic hepatitis B is stable and cannot increase the risks, the subjects can be enrolled;
Patients who had used other investigationsl drugs within 28 days before the use of this investigational drug or within 5 half-lives of the previous investigational drugs (whichever is longer) or had used investigational medical device within 28 days;
Patients who received any anti-infection vaccines (e.g. influenza vaccine, varicella vaccine etc.) within 4 weeks before enrollment;
Subjects with drug addiction or alcohol addiction (i.e., weekly alcohol consumption > 14 units, one unit of alcohol=360ml of beer or 45ml 40% liquor or 150 mL of wine)
Subjects with interstitial lung disease and clinical symptoms;
Subjects with peripheral neuropathy ≥ CTCAE grade 2
Subjects who are known to be allergic to anti-VEGF monoclonal antibody or any of its excipients, or subjects who are known to have medical history of allergic diseases or allergic constitution;
Subjects who received anti-VEGF monoclonal antibody or similar products before the study;
Pregnant and lactating women;
Patients who have poor compliance, self-care disability and cannot guarantee to follow the protocol requirements;
Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

Shawn Yu, Master contact

010-65260820

Shawn.Yu@genorbio.com

China1 site, 1 recruiting

Beijing Tiantan Hospital of Capital Medical University
Beijing, Beijing Municipality, 100050
Wenbin Li, Ph.D, 010-67098416, neure55@126.com
Recruiting

Other trials in China

About this study

Official title: An Open-label, Dose-escalated, Phase I Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetic Profiles of GB222 in Chinese Patients With Relapsed/Progressive High-grade Glioma

Conditions: Brain Tumor
Being tested: GB222 3mg/kg, GB222 5mg/kg, GB222 7.5mg/kg, GB222 10mg/kg
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GB222 3mg/kgBiological
Also called Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection
Injection, strength 100mg/bottle, intravenous infusion, 3mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; low dose group.
GB222 5mg/kgBiological
Also called Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection
Injection, strength 100mg/bottle, intravenous infusion,5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 1.
GB222 7.5mg/kgBiological
Also called Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection
Injection, strength 100mg/bottle, intravenous infusion,7.5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 2.
GB222 10mg/kgBiological
Also called Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection
Injection, strength 100mg/bottle, intravenous infusion,10mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; high dose group.

Study groups in NCT04178057
Study group	Role	What they receive
GB222 3mg/kg	Experimental	GB222 3mg/kg Receives: Biological: GB222 3mg/kg
GB222 5mg/kg	Experimental	GB222 5mg/kg Receives: Biological: GB222 5mg/kg
GB222 7.5mg/kg	Experimental	GB222 7.5mg/kg Receives: Biological: GB222 7.5mg/kg
GB222 10mg/kg	Experimental	GB222 10mg/kg Receives: Biological: GB222 10mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicity, DLT
Dose-limiting toxicity, DLT
Measured: up to 28 days
Maximum Tolerated Dose, MTD
Maximum Tolerated Dose, MTD
Measured: up to 28 days
Serious Adverse Effect, SAE
Serious Adverse Effect, SAE
Measured: up to 28 days
Adervse Effect, AE
Adervse Effect, AE
Measured: up to 28 days

Secondary outcomes (10)

Cmax
Cmax
Measured: up to 28 days
AUC 0-t
AUC 0-t
Measured: up to 28 days
AUC (0- ∞)
AUC (0- ∞)
Measured: up to 28 days
Tmax
Tmax
Measured: up to 28 days
T 1/2
T 1/2
Measured: up to 28 days
CL
CL
Measured: up to 28 days
Antidrug Antibody, ADA
Antidrug Antibody, ADA
Measured: through study completion, an average of 2 year
Objective Response Rate, ORR
Objective Response Rate, ORR
Measured: through study completion, an average of 2 year
Progress-free Survial, PFS
Progress-free Survial, PFS
Measured: through study completion, an average of 2 year
Overall Survial, OS
Overall Survial, OS
Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Oct 2018Apr 2021

First posted26 Nov 2019
Study start16 Oct 2018
Primary completionDec 2020 (estimated)
Study completionApr 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Brain TumorStudies 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: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04178057
Sponsor's protocol ID: GENOR GB222-003; V2.1
Status last verified: Nov 2019
First submitted: 24 Nov 2019
Last updated: 27 Nov 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Shawn Yu, Master

010-65260820

Shawn.Yu@genorbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Dose-escalated, Phase I Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetic Profiles of GB222 in Chinese Patients With Relapsed/Progressive High-grade Glioma
ClinicalTrials.gov ID: NCT04178057
Acronym / sponsor ID: GENOR GB222-003; V2.1
Conditions: Brain Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Oct 2018 (actual)
Primary completion: Dec 2020 (estimated)
Study completion: Apr 2021 (estimated)
First posted: 26 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
GB222 3mg/kg	Experimental	Biological: GB222 3mg/kgGB222 3mg/kg
GB222 5mg/kg	Experimental	Biological: GB222 5mg/kgGB222 5mg/kg
GB222 7.5mg/kg	Experimental	Biological: GB222 7.5mg/kgGB222 7.5mg/kg
GB222 10mg/kg	Experimental	Biological: GB222 10mg/kgGB222 10mg/kg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Age ≥ 18 years, male or female;
Understand the study procedures and contents, and voluntarily sign the written informed consent form;
Histologically or cytologically confirmed advanced high-grade glioma which failed respond to conventional treatment and is unsuitable to receive multidisciplinary treatment, WHO grades III-IV;
Disease progression (recurrence) after first-line treatment including surgery, radiotherapy and temozolomide chemotherapy;
MRI confirmed tumor progression (within 14 days before the administration of investigational product);

Key exclusion criteria (36 listed)

The subjects are not allowed to participate in this clinical study if they meet any of the following criteria:
Subjects with brain neoplasms which occur in brain stem;
Subjects with diffuse meningeal dissemination;
Subjects who previously had other malignancies (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) are not allowed to participate in the study unless he/she completely relieved at least 2 years before being enrolled in this study and requires no other treatment now or during the study period.
Subjects who have active, known or suspected autoimmune diseases;

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
GB222 3mg/kgAlso: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injectionInjection, strength 100mg/bottle, intravenous infusion, 3mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; low dose group.	Biological	GB222 3mg/kg
GB222 5mg/kgAlso: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injectionInjection, strength 100mg/bottle, intravenous infusion,5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 1.	Biological	GB222 5mg/kg
GB222 7.5mg/kgAlso: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injectionInjection, strength 100mg/bottle, intravenous infusion,7.5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 2.	Biological	GB222 7.5mg/kg
GB222 10mg/kgAlso: Recombinant humanized antivascular endothelial growth factor monoclonal antibody injectionInjection, strength 100mg/bottle, intravenous infusion,10mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; high dose group.	Biological	GB222 10mg/kg

Primary outcome

Dose-limiting toxicity, DLT
Time frame: up to 28 days
Dose-limiting toxicity, DLT
Maximum Tolerated Dose, MTD
Time frame: up to 28 days
Maximum Tolerated Dose, MTD
Serious Adverse Effect, SAE
Time frame: up to 28 days
Serious Adverse Effect, SAE
Adervse Effect, AE
Time frame: up to 28 days
Adervse Effect, AE

10 secondary outcomes

Cmax
Time frame: up to 28 days
AUC 0-t
Time frame: up to 28 days
AUC (0- ∞)
Time frame: up to 28 days
Tmax
Time frame: up to 28 days
T 1/2
Time frame: up to 28 days
CL
Time frame: up to 28 days
Antidrug Antibody, ADA
Time frame: through study completion, an average of 2 year
Objective Response Rate, ORR
Time frame: through study completion, an average of 2 year
Progress-free Survial, PFS
Time frame: through study completion, an average of 2 year
Overall Survial, OS
Time frame: through study completion, an average of 2 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 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.

Shawn Yu, Master contact

010-65260820

Shawn.Yu@genorbio.com

Wenbin Li, Ph.D principal investigator

Beijing Tiantan Hospital of Capital Medical University

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 3mg/kg, GB222 5mg/kg and GB222 7.5mg/kg in people with Brain Tumor, 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?

The sponsor lists 17 inclusion and 36 exclusion criteria. 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 27 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 (010-65260820, Shawn.Yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity, DLT (time frame: up to 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04178057.

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 27 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.