HER2-positive Breast CancerPhase 1/2NCT04170595
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection
A Phase 1/2 study testing GB221,2 mg/kg, GB221,6 mg/kg and Herceptin,6 mg/kg in people with HER2-positive Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- GB221,2 mg/kg, GB221,6 mg/kg and Herceptin,6 mg/kg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2014to Dec 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 65 years;
- Histopathologically confirmed breast cancer;
- HER-2 positive (definition: the immunohistochemistry (IHC) test of pathological samples showed HER-2 +++ or immunohistochemistry (IHC) test showed HER-2 ++ and positive FISH amplification test);
- HER2-positive breast cancer patients who have no lesion after surgery and never received anti-HER-2 treatment;
- The investigators consider that the subject has recovered from the toxic reactions caused by the previous chemotherapy 4 weeks after the last chemotherapy.
- The expected survival is 3 months or longer;
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- ECOG performance status is 0, 1 or 2;
- The left ventricular ejection fraction (LVEF)≥50%;
- The major organ function is normal and laboratory tests meet relevant criteria:
- l Hematology test:
- Hb≥90 g/L (no blood transfusion within 14 days);
- ANC≥1.5×109 /L;
- PLT≥100×109 /L; l Hepatic and renal function tests:
- TBIL≤1.5×ULN (upper limit of normal);
- ALT and AST≤2.5×ULN;
- Serum Cr ≤ULN;
- Normal coagulation function test;
- Voluntarily sign the written informed consent form
- Aged 18 to 65 years;
- Histopathologically confirmed breast cancer;
- HER-2 positive (definition: the immunohistochemistry (IHC) test of pathological samples showed HER-2 +++ or immunohistochemistry (IHC) test showed HER-2 ++ and positive FISH amplification test);
- Patients with metastatic breast cancer who failed to respond to previous chemotherapy and no more than three lines, and never received anti-HER-2 treatment(subjects in single dose group who experienced disease progression but meet other inclusion/exclusion criteria can be enrolled);
- There is at least one measurable target lesion (based on RECIST 1.1 criteria):
- According to Response Evaluation Criteria in Solid Tumors (RECIST V1.1), the target lesions must be accurately measured in at least one dimension (refer to appendix 5);
- No radiotherapy for target lesions;
- The investigators consider that the subject has recovered from the toxic reactions caused by the previous chemotherapy 4 weeks after the last chemotherapy (subjects who are receiving Xeloda monotherapy and achieve efficacy or stable disease can be enrolled in this study).
- The expected survival is 3 months or longer;
- ECOG performance status is 0, 1 or 2;
- The left ventricular ejection fraction (LVEF)≥50%;
- The major organ function is normal and laboratory tests meet relevant criteria:
- l Hematology test:
- Hb≥90 g/L (no blood transfusion within 14 days);
- ANC≥1.5×109 /L;
- PLT≥100×109 /L; l Hepatic and renal function tests:
- TBIL≤1.5×ULN (upper limit of normal);
- ALT and AST≤2.5×ULN; if there is any hepatic metastasis, ALT and AST ≤5×ULN;
- Serum Cr ≤ULN;
- Normal coagulation function test;
- Voluntarily sign the written informed consent form.
Who cannot join
- Pregnant or breastfeeding females; or women of childbearing potential who have positive urine pregnancy test; or any subjects who are able to bear or father a child but cannot or are unwilling to adopt medically acceptable effective contraceptive methods during the study period and within 3 months after the end of the study;
- Subjects who have any of the following cardiac conditions:
- Unstable angina pectoris;
- Medical history of congestive heart failure;
- Previous medical history of myocardial infarction, coronary artery bypass grafting or coronary stent implantation;
- Clinically significant pericardial diseases and valvular heart diseases;
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- Serious uncontrolled arrhythmia;
- Any other cardiac diseases which may cause safety risks for patients if they are enrolled in this study;
- Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg);
- Known HIV, HBV or HCV infection;
- Allergic constitution; known allergic to the components of the investigational product;
- Have drug abuse history or alcohol addiction history;
- Participated in other clinical studies within 4 weeks before the initiation of the study;
- Have complicated diseases which may interfere with study participation or evaluation at the discretion of the investigator, e.g., uncontrolled infection, coagulation disorders and other diseases, or the investigators consider that participation in this study may lead to greater risks for patients.
- For multiple dose groups:
- Pregnant or breastfeeding females; or women of childbearing potential who have positive urine pregnancy test; or any subjects who are able to bear or father a child but cannot or are unwilling to adopt medically acceptable effective contraceptive methods during the study period and within 3 months after the end of the study;
- Subjects with known or suspected brain metastasis: Subjects with evidence indicating signs or symptoms of brain metastasis are not allowed to participate in this study unless such brain metastasis is excluded by CT or MRI. However, subjects whose brain metastasis lesions have been controlled can be enrolled (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
- Subjects who had disease progression after previous chemotherapy with Xeloda.
- Subjects who have any of the following cardiac conditions:
- Unstable angina pectoris;
- Medical history of congestive heart failure;
- Previous medical history of myocardial infarction, coronary artery bypass grafting or coronary stent implantation;
- Clinically significant pericardial diseases and valvular heart diseases;
- Serious uncontrolled arrhythmia;
- Any other cardiac diseases which may cause safety risks for patients if they are enrolled in this study;
- Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg);
- Known HIV, HBV or HCV infection;
- Allergic constitution; known allergic to the components of the investigational product;
- Have drug abuse history or alcohol addiction history;
- Participated in other clinical studies within 4 weeks before the initiation of the study;
- Have complicated diseases which may interfere with study participation or evaluation at the discretion of the investigator, e.g., uncontrolled infection, coagulation disorders and other diseases, or the investigators consider that participation in this study may lead to greater risks for patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071
Ze Fei Jiang, Ph.D, 010-66947171, jiangzefei@medmail.com
About this study
Official title: A Randomized, Multicenter, Phase I/IIa Clinical Study to Evaluate the Tolerability, Safety, Efficacy, Pharmacokinetics and Immunogenicity of GB221 for Injection for the Treatment of HER2-positive Breast Cancer Patients
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- GB221,2 mg/kg, GB221,6 mg/kg, Herceptin,6 mg/kg, GB221,8mg/kg, GB221:2mg/kg and Capecitabi:1000mg/kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB221,2 mg/kgBiological
Also called Coprelotamab Injection
Single dose, 2mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
GB221,6 mg/kgBiological
Also called Coprelotamab Injection
Single dose 6mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
Herceptin,6 mg/kgBiological
Also called Trastuzumab Injection
Single dose group: lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
GB221,8mg/kgBiological
Also called Coprelotamab Injection
Single dose 8mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 8mg/kg for one dose, intravenous infusion, completed for over 90 minutes
GB221:2mg/kg and Capecitabi:1000mg/kgBiological
GB221:Lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose group; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.
Herceptin:2mg/kg and Capecitabin:1000mg/kgBiological
Herceptin:Lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose groups; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| GB221,2mg/kg | Experimental | Coprelotamab Injection, 2 mg/kg, Single dose, Receives: Biological: GB221,2 mg/kg |
| GB221,6mg/kg | Experimental | Coprelotamab Injection, 6 mg/kg, Single dose, Receives: Biological: GB221,6 mg/kg |
| Herceptin,6mg/kg | Active comparator | Trastuzumab Injection, 6 mg/kg, Single dose, Receives: Biological: Herceptin,6 mg/kg |
| GB221,8mg/kg | Experimental | Coprelotamab Injection, 8 mg/kg, Single dose, Receives: Biological: GB221,8mg/kg |
| GB221+ Capecitabine | Experimental | Multiple dose groups Receives: Biological: GB221:2mg/kg and Capecitabi:1000mg/kg |
| Herceptin+Capecitabine | Active comparator | Multiple dose groups Receives: Biological: Herceptin:2mg/kg and Capecitabin:1000mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose,MTD
To evaluate the efficacy and safety of GB221.
Measured: Up to 5 weeks
C max
C max
Measured: Up to 5 weeks
AUC (0- t)
AUC (0- t)
Measured: Up to 5 weeks
AUC (0- ∞ )
AUC (0- ∞ )
Measured: Up to 5 weeks
T max
T max
Measured: Up to 5 weeks
T 1/2
T 1/2
Measured: Up to 5 weeks
CL/F
CL/F
Measured: Up to 5 weeks
V/F
V/F
Measured: Up to 5 weeks
K e
K e
Measured: Up to 5 weeks
Secondary outcomes (1)
Antidrug antibody, ADA
Antidrug antibody, ADA
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start28 Mar 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ze Fei Jiang, Ph.D, Principal investigator, Affiliated Hospital of Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04170595
- Sponsor's protocol ID
- GENOR GB221-002
- Status last verified
- Mar 2021
- First submitted
- 12 Nov 2019
- Last updated
- 3 Mar 2021
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Phase I/IIa Clinical Study to Evaluate the Tolerability, Safety, Efficacy, Pharmacokinetics and Immunogenicity of GB221 for Injection for the Treatment of HER2-positive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04170595
- Acronym / sponsor ID
- GENOR GB221-002
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 20 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.
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody for injection for the treatment of HER2-positive breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GB221,2mg/kg | Experimental | Biological: GB221,2 mg/kgCoprelotamab Injection, 2 mg/kg, Single dose, |
| GB221,6mg/kg | Experimental | Biological: GB221,6 mg/kgCoprelotamab Injection, 6 mg/kg, Single dose, |
| Herceptin,6mg/kg | Active comparator | Biological: Herceptin,6 mg/kgTrastuzumab Injection, 6 mg/kg, Single dose, |
| GB221,8mg/kg | Experimental | Biological: GB221,8mg/kgCoprelotamab Injection, 8 mg/kg, Single dose, |
| GB221+ Capecitabine | Experimental | Biological: GB221:2mg/kg and Capecitabi:1000mg/kgMultiple dose groups |
| Herceptin+Capecitabine | Active comparator | Biological: Herceptin:2mg/kg and Capecitabin:1000mg/kgMultiple dose groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Aged 18 to 65 years;
- Histopathologically confirmed breast cancer;
- HER-2 positive (definition: the immunohistochemistry (IHC) test of pathological samples showed HER-2 +++ or immunohistochemistry (IHC) test showed HER-2 ++ and positive FISH amplification test);
- HER2-positive breast cancer patients who have no lesion after surgery and never received anti-HER-2 treatment;
- The investigators consider that the subject has recovered from the toxic reactions caused by the previous chemotherapy 4 weeks after the last chemotherapy.
Key exclusion criteria (31 listed)
- Pregnant or breastfeeding females; or women of childbearing potential who have positive urine pregnancy test; or any subjects who are able to bear or father a child but cannot or are unwilling to adopt medically acceptable effective contraceptive methods during the study period and within 3 months after the end of the study;
- Subjects who have any of the following cardiac conditions:
- Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg);
- Known HIV, HBV or HCV infection;
- Allergic constitution; known allergic to the components of the investigational product;
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 |
|---|---|---|
| GB221,2 mg/kgAlso: Coprelotamab InjectionSingle dose, 2mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2 mg/kg for one dose, intravenous infusion, completed for over 90 minutes | Biological | GB221,2mg/kg |
| GB221,6 mg/kgAlso: Coprelotamab InjectionSingle dose 6mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes | Biological | GB221,6mg/kg |
| Herceptin,6 mg/kgAlso: Trastuzumab InjectionSingle dose group: lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes | Biological | Herceptin,6mg/kg |
| GB221,8mg/kgAlso: Coprelotamab InjectionSingle dose 8mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 8mg/kg for one dose, intravenous infusion, completed for over 90 minutes | Biological | GB221,8mg/kg |
| GB221:2mg/kg and Capecitabi:1000mg/kgGB221:Lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose group; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. | Biological | GB221+ Capecitabine |
| Herceptin:2mg/kg and Capecitabin:1000mg/kgHerceptin:Lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose groups; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. | Biological | Herceptin+Capecitabine |
Primary outcome
maximum tolerated dose,MTD
Time frame: Up to 5 weeks
To evaluate the efficacy and safety of GB221.
C max
Time frame: Up to 5 weeks
C max
AUC (0- t)
Time frame: Up to 5 weeks
AUC (0- t)
AUC (0- ∞ )
Time frame: Up to 5 weeks
AUC (0- ∞ )
T max
Time frame: Up to 5 weeks
T max
T 1/2
Time frame: Up to 5 weeks
T 1/2
CL/F
Time frame: Up to 5 weeks
CL/F
V/F
Time frame: Up to 5 weeks
V/F
K e
Time frame: Up to 5 weeks
K e
1 secondary outcome
Antidrug antibody, ADA
Time frame: Up to 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
Ze Fei Jiang, Ph.D principal investigator
Affiliated Hospital of Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GB221,2 mg/kg, GB221,6 mg/kg and Herceptin,6 mg/kg in people with HER2-positive Breast 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?
The sponsor lists 39 inclusion and 31 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 3 Mar 2021. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
maximum tolerated dose,MTD (time frame: Up to 5 weeks). The study lists 9 primary outcomes in all. 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 3 Mar 2021.