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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04175171




Registration number
NCT04175171
Ethics application status
Date submitted
12/11/2019
Date registered
22/11/2019
Date last updated
18/12/2019

Titles & IDs
Public title
Clinical Trial of Comparative Study of GB221 Pharmacokinetics
Scientific 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)
Secondary ID [1] 0 0
GB221-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Coprelotamab Injection
Treatment: Drugs - Trastuzumab Injection

Experimental: GB221 - Coprelotamab Injection, 8mg/kg, single dose

Active Comparator: Herceptin - Trastuzumab Injection, 8mg/kg, single dose


Treatment: Drugs: Coprelotamab Injection
The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.

Treatment: Drugs: Trastuzumab Injection
The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
physical examination
Timepoint [1] 0 0
Up to 84 days
Primary outcome [2] 0 0
adverse event
Timepoint [2] 0 0
Up to 84 days
Primary outcome [3] 0 0
blood pressure
Timepoint [3] 0 0
Up to 84 days
Primary outcome [4] 0 0
heart rate
Timepoint [4] 0 0
Up to 84 days
Primary outcome [5] 0 0
respiration rate
Timepoint [5] 0 0
Up to 84 days
Primary outcome [6] 0 0
oxygen saturation
Timepoint [6] 0 0
Up to 84 days
Primary outcome [7] 0 0
temperature
Timepoint [7] 0 0
Up to 84 days
Secondary outcome [1] 0 0
C max
Timepoint [1] 0 0
Up to 84 days
Secondary outcome [2] 0 0
t max
Timepoint [2] 0 0
Up to 84 days
Secondary outcome [3] 0 0
AUC
Timepoint [3] 0 0
Up to 84 days
Secondary outcome [4] 0 0
CL
Timepoint [4] 0 0
Up to 84 days
Secondary outcome [5] 0 0
t ½
Timepoint [5] 0 0
Up to 84 days
Secondary outcome [6] 0 0
V
Timepoint [6] 0 0
Up to 84 days

Eligibility
Key inclusion criteria
To be enrolled in the study, subjects must meet the following criteria

1. Males aged 18 to 45 years.

2. Healthy as judged by medical examination and medical history, and clinical chemistry
and hematology screening.

3. Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive)
up to a maximum of 90 kg.

4. Normal or non-clinically significant ECG.

5. Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate
(40 -100 bpm, inclusive).

6. Willingness to give written and informed consent prior to any studyrelated procedures
being conducted
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be ineligible for the study if any of the following criteria apply:

1. Receipt of any investigational agent or drug within 4 weeks of entry to the study.

2. 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.

3. Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.

4. Clinically significant drug allergy or sensitivity to any medication.

5. A history of chronic or recurrent infections.

6. A recent history of surgery.

7. History or presence of malignancy (with the exception of successfully treated basal
cell carcinoma).

8. Inability to communicate or cooperate with the Principal Investigator because of
English language difficulties or poor mental development.

9. A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting
tobacco use less than 10 cigarettes per day).

10. A positive urine test for drugs of abuse or alcohol either at screening or on the day
of admittance for drug administration.

11. Vaccination of any type within the previous month.

12. 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.

13. Consumption of more than 3 standard drinks per day, and not able to abstain from
alcohol totally within 24 hours of dose administration.

14. Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.

15. History of asthma or other chronic respiratory disease in the past 5 years.

16. History of neurological or neuromuscular disease.

17. History of hypertension or cardiovascular disease, including congestive heart failure
and cardiomyopathy or a clinically significant echocardiogram finding at the screening
visit.

18. History of bladder or urethral disease.

19. Smoking cigarettes > 10 per day.

20. Any other condition which in the view of the Principal Investigator is likely to
interfere with the study or put the subject at risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/03/2012
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Limited - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genor Biopharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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®.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04175171
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrewn Redfer, PhD; MBBS
Address 0 0
Linear Clinical Research Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04175171