Breast CancerPhase 1NCT04905667
Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®
A Phase 1 study testing GB221 and Herceptin in people with Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GB221 and Herceptin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2019to 11 Sep 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Signed informed consent form;
- 2. Healthy adult volunteers aged between 18 and 45, male or female;
- 3. Medical examination as required within 28 days, body mass index (BMI) 19.0 ~ 24.0, weight≥50 kg for men, ≥45 kg for women, and≤ 75 kg for both;
- 4. Agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months;
- 5.Subject can communicate well with the investigators and complete the study according to the study regulations.
Who cannot join
- 1. Pregnant or lactating women, or positive in either blood or urine pregnancy test; or unwilling to take effective contraceptive measures during the trial and within 6 months after the end of the trial at fertile age;
- 2. Allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin E (IgE) test;
- 3. History of drug abuse, or positive urine test for drug;
- 4. History of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. History of high blood pressure, or clinically significant systolic blood pressure≥140 mmHg/diastolic blood pressure≥90 mmHg;
- 5. Family history of cancer, or tumor markers (male: CEA, AFP, PSA, CA-125; Female: CEA, AFP, CA-153, CA-125) positive.
- 6. Participated in other clinical trials of drug or used drugs harmful to major organs within 3 months;
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- 7. Blood donation within 3 months;
- 8. Used prescription or OTC drugs within 14 days;
- 9. Left ventricular ejection fraction (LVEF) < 60%;
- 10. ALT or AST > 1.5 ULN, Cr > ULN;
- 11. WBC < 0.8 LLN or > 1.2 ULN; ANC < 0.8 LLN; PLT < 0.8 LLN; HGB < 0.9LLN.
- 12. HBs-Ag, HCV-Ab, anti-HIV or TP-Ab positive;
- 13. Anti-drug antibody (ADA) test positive;
- 14.History of psychosis;
- 15. History of postural hypotension;
- 16. More than 5 cigarettes per day;
- 17. More than 28 units of alcohol per week; Or alcohol breath test positive within 24 hours before pre-dose;
- 18. History of dizziness of blood or needle;
- 19. Unsuitable for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou, 510799
About this study
Official title: A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.
Read the detailed description
Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.
- Conditions
- Breast Cancer
- Being tested
- GB221, Herceptin
- Keywords
- Breast cancer, Pharmacokinetics, anti-HER-2 human monoclonal antibody, Herceptin, GB221
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB221Drug
6 mg/kg, single dose, intravenous infusion, 90-100 min
HerceptinDrug
6 mg/kg, single dose, intravenous infusion, 90-100 min
| Study group | Role | What they receive |
|---|---|---|
| GB221 group | Experimental | 6 mg/kg, single dose, intravenous infusion, 90-100 min Receives: Drug: GB221 |
| Herceptin group | Active comparator | 6 mg/kg, single dose, intravenous infusion, 90-100 min Receives: Drug: Herceptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®
Measured: Day 43
AUC0-∞
compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®
Measured: Day 43
Cmax
compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®
Measured: Day 43
Secondary outcomes (7)
Tmax
compare the pharmacokinetic Tmax parameters of GB221 and Herceptin ®
Measured: Day 43
t1/2
compare the pharmacokinetic t1/2 parameters of GB221 and Herceptin ®
Measured: Day 43
CL
compare the pharmacokinetic CL parameters of GB221 and Herceptin ®
Measured: Day 43
Vd
compare the pharmacokinetic Vd parameters of GB221 and Herceptin ®
Measured: Day 43
Ke
compare the pharmacokinetic Ke parameters of GB221 and Herceptin ®
Measured: Day 43
ADA
compare the incidence of ADA in of GB221 and Herceptin ® group
Measured: Day 43
Nab
compare the incidence of Nab in of GB221 and Herceptin ® group
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start13 Nov 2019
- Primary completion8 Sep 2020
- Study completion11 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905667
- Sponsor's protocol ID
- 221-005
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 27 May 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 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04905667
- Acronym / sponsor ID
- 221-005
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Pharmacokinetics, anti-HER-2 human monoclonal antibody, Herceptin, GB221
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 8 Sep 2020 (actual)
- Study completion
- 11 Sep 2020 (actual)
- First posted
- 27 May 2021 (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.
This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.
Detailed description
Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB221 group | Experimental | Drug: GB2216 mg/kg, single dose, intravenous infusion, 90-100 min |
| Herceptin group | Active comparator | Drug: Herceptin6 mg/kg, single dose, intravenous infusion, 90-100 min |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Signed informed consent form;
- 2. Healthy adult volunteers aged between 18 and 45, male or female;
- 3. Medical examination as required within 28 days, body mass index (BMI) 19.0 ~ 24.0, weight≥50 kg for men, ≥45 kg for women, and≤ 75 kg for both;
- 4. Agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months;
- 5.Subject can communicate well with the investigators and complete the study according to the study regulations.
Key exclusion criteria (19 listed)
- 1. Pregnant or lactating women, or positive in either blood or urine pregnancy test; or unwilling to take effective contraceptive measures during the trial and within 6 months after the end of the trial at fertile age;
- 2. Allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin E (IgE) test;
- 3. History of drug abuse, or positive urine test for drug;
- 4. History of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. History of high blood pressure, or clinically significant systolic blood pressure≥140 mmHg/diastolic blood pressure≥90 mmHg;
- 5. Family history of cancer, or tumor markers (male: CEA, AFP, PSA, CA-125; Female: CEA, AFP, CA-153, CA-125) positive.
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 |
|---|---|---|
| GB2216 mg/kg, single dose, intravenous infusion, 90-100 min | Drug | GB221 group |
| Herceptin6 mg/kg, single dose, intravenous infusion, 90-100 min | Drug | Herceptin group |
Primary outcome
AUC0-t
Time frame: Day 43
compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®
AUC0-∞
Time frame: Day 43
compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®
Cmax
Time frame: Day 43
compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®
7 secondary outcomes
Tmax
Time frame: Day 43
t1/2
Time frame: Day 43
CL
Time frame: Day 43
Vd
Time frame: Day 43
Ke
Time frame: Day 43
ADA
Time frame: Day 43
Nab
Time frame: Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 GB221 and Herceptin in people with 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 5 inclusion and 19 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: finished, as of the sponsor's last update on 27 May 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: Day 43). The study lists 3 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 27 May 2021.