Metastatic Breast CancerPhase 1NCT04175171
Clinical Trial of Comparative Study of GB221 Pharmacokinetics
A Phase 1 study testing Coprelotamab Injection and Trastuzumab Injection in people with Metastatic Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in Australia.
Trial summary
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®. 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
- Metastatic Breast Cancer
- What is being tested?
- Coprelotamab Injection and Trastuzumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Nov 2011to 8 Mar 2012
- 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
Who may be able to join
- To be enrolled in the study, subjects must meet the following criteria
- Males aged 18 to 45 years.
- Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
- Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
- Normal or non-clinically significant ECG.
- Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
- Willingness to give written and informed consent prior to any studyrelated procedures being conducted
Who cannot join
- Subjects will be ineligible for the study if any of the following criteria apply:
- Receipt of any investigational agent or drug within 4 weeks of entry to the study.
- Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
- Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
- Clinically significant drug allergy or sensitivity to any medication.
- A history of chronic or recurrent infections.
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- A recent history of surgery.
- History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
- Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
- A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
- A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
- Vaccination of any type within the previous month.
- A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
- Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
- Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.
- History of asthma or other chronic respiratory disease in the past 5 years.
- History of neurological or neuromuscular disease.
- History of hypertension or cardiovascular disease, including congestive heart failure and cardiomyopathy or a clinically significant echocardiogram finding at the screening visit.
- History of bladder or urethral disease.
- Smoking cigarettes > 10 per day.
- Any other condition which in the view of the Principal Investigator is likely to interfere with the study or put the subject at risk.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Linear Clinical Research Limited
Nedlands, Western Australia, 6009
About this study
Official title: A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)
The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Coprelotamab Injection, Trastuzumab Injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coprelotamab InjectionDrug
Also called GB221
The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.
Trastuzumab InjectionDrug
Also called Herceptin
The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| GB221 | Experimental | Coprelotamab Injection, 8mg/kg, single dose Receives: Drug: Coprelotamab Injection |
| Herceptin | Active comparator | Trastuzumab Injection, 8mg/kg, single dose Receives: Drug: Trastuzumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical examination
physical examination
Measured: Up to 84 days
adverse event
adverse event
Measured: Up to 84 days
blood pressure
blood pressure
Measured: Up to 84 days
heart rate
heart rate
Measured: Up to 84 days
respiration rate
respiration rate
Measured: Up to 84 days
oxygen saturation
oxygen saturation
Measured: Up to 84 days
temperature
temperature
Measured: Up to 84 days
Secondary outcomes (6)
C max
C max
Measured: Up to 84 days
t max
t max
Measured: Up to 84 days
AUC
AUC
Measured: Up to 84 days
CL
CL
Measured: Up to 84 days
t ½
t ½
Measured: Up to 84 days
V
V
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 start7 Nov 2011
- Primary completion8 Jan 2012
- Study completion8 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrewn Redfer, PhD; MBBS, Principal investigator, Linear Clinical Research Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175171
- Sponsor's protocol ID
- GB221-001
- Status last verified
- Nov 2019
- First submitted
- 12 Nov 2019
- Last updated
- 18 Dec 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 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Comparative Phase I Study to Evaluate the Safety and Pharmacokinetics of Single Intravenous (IV) Administration of GB221 Versus Herceptin® (Trastuzumab)
- ClinicalTrials.gov ID
- NCT04175171
- Acronym / sponsor ID
- GB221-001
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2011 (actual)
- Primary completion
- 8 Jan 2012 (actual)
- Study completion
- 8 Mar 2012 (actual)
- 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 is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
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 |
|---|---|---|
| GB221 | Experimental | Drug: Coprelotamab InjectionCoprelotamab Injection, 8mg/kg, single dose |
| Herceptin | Active comparator | Drug: Trastuzumab InjectionTrastuzumab Injection, 8mg/kg, single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- To be enrolled in the study, subjects must meet the following criteria
- Males aged 18 to 45 years.
- Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
- Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
- Normal or non-clinically significant ECG.
Key exclusion criteria (21 listed)
- Receipt of any investigational agent or drug within 4 weeks of entry to the study.
- Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
- Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
- Clinically significant drug allergy or sensitivity to any medication.
- A history of chronic or recurrent infections.
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 |
|---|---|---|
| Coprelotamab InjectionAlso: GB221The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump. | Drug | GB221 |
| Trastuzumab InjectionAlso: HerceptinThe single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump. | Drug | Herceptin |
Primary outcome
physical examination
Time frame: Up to 84 days
physical examination
adverse event
Time frame: Up to 84 days
adverse event
blood pressure
Time frame: Up to 84 days
blood pressure
heart rate
Time frame: Up to 84 days
heart rate
respiration rate
Time frame: Up to 84 days
respiration rate
oxygen saturation
Time frame: Up to 84 days
oxygen saturation
temperature
Time frame: Up to 84 days
temperature
6 secondary outcomes
C max
Time frame: Up to 84 days
t max
Time frame: Up to 84 days
AUC
Time frame: Up to 84 days
CL
Time frame: Up to 84 days
t ½
Time frame: Up to 84 days
V
Time frame: Up to 84 days
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 18 Dec 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.
Andrewn Redfer, PhD; MBBS principal investigator
Linear Clinical Research Limited
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 Coprelotamab Injection and Trastuzumab Injection in people with Metastatic Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in Australia.
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 7 inclusion and 21 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 18 Dec 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 Australia. 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?
physical examination (time frame: Up to 84 days). The study lists 7 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 18 Dec 2019.