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Trial registered on ANZCTR


Registration number
ACTRN12621000573853
Ethics application status
Approved
Date submitted
3/02/2021
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A study comparing the study drug BP02 and Herceptin® in healthy men.
Scientific title
A randomized, double-blind, single-dose, 3-way, parallel-group, comparator-controlled study to evaluate the pharmacokinetic, safety, tolerability, and immunogenicity of BP02 (trastuzumab) compared to Herceptin® (EU approved and US-licensed) in healthy adult male volunteers.
Secondary ID [1] 303308 0
None
Universal Trial Number (UTN)
Not Applicable
Trial acronym
BP02-101
Linked study record
Not Applicable

Health condition
Health condition(s) or problem(s) studied:
HER2 Positive Tumours 320527 0
Condition category
Condition code
Cancer 318384 318384 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test Product, Dose and Route of Administration:

BP02 (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion.

Reference Therapy, Dose and Route of Administration:

EU-sourced Herceptin (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion.
US-sourced Herceptin (trastuzumab): 6 mg/kg administered as a 90-minute intravenous infusion.

About 111 healthy men will be enrolled in the study. The study requires a 4-night stay at participating sites, and 10 clinic visits, and 2 phone check-ups. Every person in the study will receive a 6 mg/kg dose of BP02 or EU-Herceptin® or US-Herceptin®.

Participants have a 1/3 chance of getting each drug. Participants will not know which drug is being administered, but their study doctor can find out in an emergency.

The study will have blinded and unblinding study team, where in the unblinded study team at site would be responsible for preparing the Investigational Product (IP) infusion as per the randomization schedule. The records would be verified by the unblinded Clinical Research Associate (CRA) during on-site visits.
Intervention code [1] 319609 0
Treatment: Drugs
Comparator / control treatment
EU- Herceptin®
US- Herceptin®
Strength: 150 mg vial.
Dose: 6 mg/kg.
Route of Administration: intravenous infusion.
Dosing Instructions:
Subjects will receive one dose of either BP02 or EU-Herceptin or US-Herceptin at a dose of 6 mg/kg as a single intravenous infusion over 90 minutes on Day 1 of the study.
Control group
Active

Outcomes
Primary outcome [1] 326362 0
- Pharmacokinetic parameters Cmax , AUC0-t and AUC0-inf of trastuzumab in serum.
Timepoint [1] 326362 0
- Preinfusion (or 0 h), At End of infusion (1.5 h), 0.5 h, 1 h, 4 h, and 6 h after the end of infusion, 24 h, 48 h, 72 h, and 96 h, Day 8 (168 h), Day 15 (336 h), Day 22 (504 h), Day 29 (672 h), Day 36 (840 h), Day 50 (1176 h), Day 64 (1512 h), and Day 78.
Secondary outcome [1] 391183 0
- Pharmacokinetic parameters tmax, t½, lambda z, and CL of trastuzumab in serum.
Timepoint [1] 391183 0
Preinfusion (or 0 h), At End of infusion (1.5 h), 0.5 h, 1 h, 4 h, and 6 h after the end of infusion, 24 h, 48 h, 72 h, and 96 h, Day 8 (168 h), Day 15 (336 h), Day 22 (504 h), Day 29 (672 h), Day 36 (840 h), Day 50 (1176 h), Day 64 (1512 h), and Day 78.
Secondary outcome [2] 392684 0
- Immunogenicity assessed by the incidence of ADA, including Nab by using Serum sample.
Timepoint [2] 392684 0
On Day 1, it is at 0 hour i.e. pre-dose: within 1 hour of infusion), On day 50, it is 1176 hour (± 1 day), On day 78, it is 1848 h (± 3 days) Study Exit (or early termination).
Secondary outcome [3] 392686 0
- Safety and tolerability assessed by clinical laboratory tests, vital signs, 12 lead ECGs, echocardiogram, physical examinations, assessment of AEs, infusion related reactions, and concomitant medications.
Timepoint [3] 392686 0
Hematology, Chemistry and Urine analysis will be done at day -1, 2, 4, 6, 7, 9, 11, 13
Coagulation will be done at day -1, 4
Thyroid hormone will be done at day -28 to -2.
ECG will be done at day -1, 2, 3, 4, 6, 8, 13
Echocardiogram will be done at day -28 to -2, 8, 22, 78
Physical Examination will be done at day -1, 6, 7, 8, 9, 10, 11, 12, 13
Assessment of AEs and Concomitant medications will be done at day -1, 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12, 13
Infusion related reaction will be done at day 1, 2, 3.

Eligibility
Key inclusion criteria

1. Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the Investigator.

2. Healthy adult male subjects, 18 to 65 years (both inclusive) of age at the time of signing informed consent.

3. Having body mass index (BMI) between 18 to 30 kg/m2 and body weight between 50 to 100 kg (all inclusive).

4. Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, pulse rate, body temperature, including respiratory rate) as judged by the Investigator.

5. Subjects who are considered healthy as determined by clinically acceptable findings of hematology, biochemistry, coagulation tests, urinalysis, 12-lead ECG, and echocardiogram.


6. Subjects with normal thyroid function (subjects on thyroid supplementation therapy will not be eligible) at screening.

7. Subjects must refrain from donating sperm or fathering a child during the study and until 9 months after administration of BP02, EU-Herceptin or US-Herceptin administration by agreeing to use (with their female partner) 2 acceptable contraceptives.

8. Non-smokers or casual smokers who smoke no more than 5 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking 48 hours prior to admission to inpatient component of treatment period.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects are excluded from the study if any of the following criteria apply:
1. Known history of hypersensitivity or allergic reactions to trastuzumab or any of its excipients.
2. History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.
3. Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
4. Subjects with LVEF of < 60 % on screening echocardiogram should be excluded from the study.
5. Sites are to adhere to local and institutional guidelines for exclusion of subjects with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and suspected coronavirus disease-2019 (COVID-19) infection/testing regarding the enrollment of subjects.
6. History of any cancer, including carcinoma in situ.
7. Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
8. Use of prescription or non-prescription drugs, including herbal and dietary supplements (including St. John’s Wort, grapefruit) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety.
9. Use of hematopoietic growth factors, monoclonal antibodies, or immunoglobulins within 6 months prior to screening or 5 half-lives, whichever is longer.
10. Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
11. Difficulty in blood sampling or difficulty in accessibility of veins.
12. Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator and/or a positive test result in breath alcohol done before check-in.
13. Subjects with a history of drug abuse or positive drug test at screening or admission.
14. Blood donation within 90 days prior to commencement of study and during the study.
15. Participation in an investigational antibody-based study within 6 months (from postdose follow-up) and any other investigational study within 90 days prior to dosing.
16. Participation in a study with trastuzumab or HER2 targeted antibody or any prior exposure to these drugs.
17. Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
18. Any persons who are:
- an employee of the Principal Investigator, clinical center, contract research organization (CRO) or Sponsor.
- a relative of an employee of the clinical center, the Investigators, CRO, or the Sponsor.

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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 assessing the outcomes
Intervention assignment
Parallel
Other design features
None
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
The Statistical Analysis Plan (SAP) will be developed and finalized before database lock and will describe the subject analysis sets to be included in the analyses, and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints.
All analyses, summaries, and listings will be performed using SAS software (Version 9.4 or higher).
The following descriptive statistics will be used as applicable to summarize the study data unless otherwise specified:
• Continuous variables: sample size (n), mean, standard deviation (SD), median, minimum, and maximum.
• Categorical variables: frequencies and percentages.

Individual subject data will be presented in listings.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
Date of last participant enrolment
Anticipated
11/10/2021
Actual
Date of last data collection
Anticipated
17/12/2021
Actual
Sample size
Target
111
Accrual to date
Final
Recruitment outside Australia
Country [1] 23417 0
New Zealand
State/province [1] 23417 0

Funding & Sponsors
Funding source category [1] 307722 0
Commercial sector/Industry
Name [1] 307722 0
CuraTeQ Biologics Private Limited
Country [1] 307722 0
India
Primary sponsor type
Commercial sector/Industry
Name
CuraTeQ Biologics Private Limited
Address
Located at Plot No.2,
Maitrivihar, Ameerpet,
Hyderabad, Telangana, India, 500 038
Country
India
Secondary sponsor category [1] 308421 0
Commercial sector/Industry
Name [1] 308421 0
IQVIA RDS Pty. Limited
Address [1] 308421 0
Unit A, 2 Rothwell Avenue, Rosedale
Auckland 0632, New Zealand
Country [1] 308421 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307749 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 307749 0
133 Molesworth Street PO Box 5013 Wellington 6011
Ethics committee country [1] 307749 0
New Zealand
Date submitted for ethics approval [1] 307749 0
27/10/2020
Approval date [1] 307749 0
25/11/2020
Ethics approval number [1] 307749 0
20/STH/190

Summary
Brief summary
Herceptin® (trastuzumab) is approved for the treatment of HER2-positive cancers.
CuraTeQ has developed BP02 as a trastuzumab biosimilar. This study aims to show that BP02 has a high degree of similarity to Herceptin, in terms of:
- Levels of drug in the blood over time
- Safety and, side effects
- The development of anti-drug antibodies.
Approximately 111 healthy males will be enrolled in the study.
Participants will receive a single 6mg/kg mg dose of either BP02, US-licensed Herceptin, or EU-approved Herceptin. The dose will be administered as an intravenous (IV) infusion over approximately 90 minutes.
Blood samples to measure study drug levels and antibodies will be collected at specific time points. Safety will be
monitored, and any changes in health will be recorded. The results will be used to inform further development of BP02.
Trial website
None
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 108366 0
Dr Christian Schwabe
Address 108366 0
Auckland Clinical Studies Ltd
PO Box 8963,
Suburb: Auckland
Postcode: 1150,
Country 108366 0
New Zealand
Phone 108366 0
+64 9 373 3474
Fax 108366 0
+64 9 373 3479
Email 108366 0
[email protected]
Contact person for public queries
Name 108367 0
Disha Dadke
Address 108367 0
CuraTeQ Biologics Private Limited,
Unit XVII,SyNo.77&78,
Indrakaran (v) Sangareddy Dist Hyderabad -502329
Country 108367 0
India
Phone 108367 0
+918455255222
Fax 108367 0
Email 108367 0
[email protected]
Contact person for scientific queries
Name 108368 0
Disha Dadke
Address 108368 0
CuraTeQ Biologics Private Limited,
Unit XVII,SyNo.77&78,
Indrakaran (v) Sangareddy Dist Hyderabad -502329
Country 108368 0
India
Phone 108368 0
+918455255222
Fax 108368 0
Email 108368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10397Ethical approval    381327-(Uploaded-31-01-2021-21-54-17)-Study-related document.pdf



Results publications and other study-related documents

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