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Breast CancerPhase 1NCT05471648

A Pharmacokinetic Study Comparing EG1206A and Perjeta (Pertzumab) in Healthy Male Volunteers

A Phase 1 study testing 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection and Perjeta (US origin) 420 mg in 14 mL Injection in people with Breast Cancer, run by EirGenix, Inc. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection and Perjeta (US origin) 420 mg in 14 mL Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
1 siteGermany
Study dates
16 May 2022to 24 Jan 2023
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 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • aged 18 to 55 years
  • overtly healthy as determined by medical evaluation
  • Body weight of at least 50 kg and not higher than 105 kg at screening
  • BMI above/equal to 18.0 and below/equal to 30.0 kg/m2 at screening
  • Male
  • Agrees to the following during the treatment period and until 3 months after administration:
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  • Be and remain abstinent from heterosexual intercourse OR agree to use a male condom and female partners of childbearing potential must use an additional highly effective contraceptive method
  • Abstain from donating sperm.
  • Signed informed consent
  • Valid COVID-19 immunization status as per current regulations

Who cannot join

  • History or evidence of any clinically relevant disease, as judged by the investigator
  • Any medical disorder, condition, or history of such that would impair the participant's ability to participate or complete this trial in the opinion of the investigator
  • Pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the IMP will not be normal
  • Known or suspected hypersensitivity to the IMPs (active substances, or excipients of the preparations)
  • Known severe allergies e.g., allergies to more than 3 allergens
  • Relevant diseases within the last 4 weeks before IMP administration
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  • Febrile illness within 2 weeks before IMP administration.
  • History of known or suspected malignant tumors
  • Known or suspected disorder of the liver
  • Use of systemic/topical medicines/substances which oppose the trial objectives, or which might influence them within 4 weeks before IMP administration
  • Regular use of therapeutic or recreational drugs or supplements
  • Use of any herbal products or St. John's wort from 4 weeks before IMP administration
  • Prior treatment with pertuzumab
  • Smoking
  • History of alcohol or drug abuse
  • Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
  • Intake of alcohol containing food and beverages from 48 h prior to admission to the ward
  • Regular daily consumption of more than 1 L of methylxanthine-containing beverages
  • Excluded physical therapies that might alter the PK or safety results of the trial from 7 days before IMP administration until follow-up
  • Strenuous physical exercise or sauna visit with 72 h before admission to the ward
  • Donation of more than 100 mL of whole blood or plasma within 4 weeks or approximately 500 mL whole blood within 3 months before IMP administration
  • Plasmapheresis within 3 months before IMP administration
  • Previous or concomitant participation in another clinical trial with IMP(s)
  • Clinically relevant findings in the ECG
  • LVEF below 55%
  • Systolic blood pressure below 100 mmHg or above 140 mmHg
  • Diastolic blood pressure below 50 mmHg or above 90 mmHg
  • Heart rate below 50 beats/ min or above 90 beats/min
  • Clinically relevant findings in the physical examination that may affect the objectives of the trial, or the safety of the participant
  • Poor venous access
  • Clinically relevant deviations of the screened safety laboratory parameters
  • Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, gamma glutamyl transpeptidase, or total bilirubin above 1.2 upper limit of normal
  • Thyroid disorders as evidenced by assessment of thyroid stimulating hormone (TSH) level outside the normal reference range
  • Positive results for hepatitis B virus surface antigen, hepatitis C virus antibodies, human immune deficiency virus antibodies, and human immune deficiency virus antigen
  • Positive urine drug test
  • Positive alcohol test
  • Positive cotinine test
  • Any criteria which, in the opinion of the investigator, preclude participation for scientific reasons, for reasons of compliance, or for reasons of the participant's safety
  • Close affiliation with the investigational site
  • Vulnerable participants who are e.g., institutionalized due to regulatory or juridical order dependent on sponsor, site, or investigator or not able to consent, respectively.
  • History of COVID-19 within 2 months prior to screening
  • Long COVID-19 syndrome or other clinically relevant COVID-19 related symptoms or sequelae
  • Positive SARS-CoV-2 viral ribonucleic acid (RNA) test at admission
  • No SARS-CoV-2 vaccinations should be booked within 14 days before IMP administration and until last trial visit.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • CRS Clinical Research Services Berlin GmbH

    Berlin, 13353

Other trials in Germany

About this study

Official title: Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) Sourced From US and EU Administered to Healthy Male Volunteers

This trial is a single-center, single-dose, double-blind, parallel-group, randomized, 3-arm PK trial in healthy male volunteers comparing a biosimilar pertuzumab (EG1206A) to a single intravenous (i.v.) infusion to both European Union (EU) and United States of America (US) reference products.

Read the detailed description

This trial is part of a clinical development program developing a biosimilar pertuzumab, comparing the PK, safety and tolerability and immunogenicity of pertuzumab after a single intravenous (i.v.) infusion.

It assess the bioequivalence, PK characteristics, safety and tolerability as well as the immunogenicity of a test preparation containing 420 mg pertuzumab (EG1206A EirGenix Pertuzumab) as compared to marketed reference (EU and US) after a single dose i.v. infusion over 60 minutes in fasted state.

Conditions
Breast Cancer
Being tested
420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection, Perjeta (US origin) 420 mg in 14 mL Injection
Keywords
HER2 positive, early stage breast cancer, metastatic breast cancer, combination therapy, inhibiting MAP Kinase, P13K/Akt
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 420 mg EG1206A EirGenix Pertuzumab in 14 mL InjectionDrug

    Also called Pertuzumab

    Healthy volunteers receive pertuzumab (EG1206A, 420 mg, single dose)

  • Perjeta (EU origin) 420 mg in 14 mL InjectionDrug

    Also called Pertuzumab

    Healthy volunteers receive pertuzumab (Perjeta (EU origin) 420 mg, single dose)

  • Perjeta (US origin) 420 mg in 14 mL InjectionDrug

    Also called Pertuzumab

    Healthy volunteers receive pertuzumab (Perjeta (US origin), 420 mg, single dose)

Study groups in NCT05471648
Study groupRoleWhat they receive
420 mg EirGenix PertuzumabExperimentalEirGenix Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.
Receives: Drug: 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection
420 mg Pertuzumab Perjeta EU OriginActive comparatorEU Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.
Receives: Drug: Perjeta (EU origin) 420 mg in 14 mL Injection
420 mg Pertuzumab Perjeta US OriginActive comparatorUS Pertuzumab given intravenous with an infusion bag as a single dose of 420 mg over 60min.
Receives: Drug: Perjeta (US origin) 420 mg in 14 mL Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-inf of pertuzumab

    Area under the plasma concentration-time curve, from time 0 h extrapolated to infinity

    Measured: Pre-dose to day 91, 21 timepoints

Secondary outcomes (8)

  1. Cmax

    Peak plasma concentration of a pertuzumab after administration

    Measured: Pre-dose to day 91, 21 timepoints

  2. tmax

    Time to reach peak plasma concentration of pertuzumab after administration

    Measured: Pre-dose to day 91, 21 timepoints

  3. t1/2

    Terminal elimination half-life

    Measured: Pre-dose to day 91, 21 timepoints

  4. Drug clearance (CL)

    Total clearance

    Measured: Pre-dose to day 91, 21 timepoints

  5. Volume of distribution (Vd)

    The apparent volume in which pertuzumab is distributed

    Measured: Pre-dose to day 91, 21 timepoints

  6. AUC0-last of pertuzumab

    Area under the plasma concentration-time curve, from time 0 h to last measured timepoint

    Measured: Pre-dose to day 91, 21 timepoints

  7. Frequency of treatment-emergent adverse events (AEs)

    Measured: Day 1 to day 91

  8. Immunogenicity: Anti-drug antibodies (ADA) and neutralizing antibodies (NAb)

    Analysis of anti-drug antibodies (ADA) and neutralizing antibodies (NAb; only assessed following confirmed positive ADA results)

    Measured: Pre-dose to day 91, 7 timepoints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2022
  2. Study start16 May 2022
  3. Primary completion24 Jan 2023
  4. Study completion24 Jan 2023

Resources

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
Model description
Phase 1, Double-Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Trial of EirGenix' Pertuzumab and Perjeta® (Pertuzumab) sourced from US and EU Administered to Healthy Male Volunteers
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05471648
Sponsor's protocol ID
EGC101
Other IDs
2021-006769-40
Status last verified
Jan 2023
First submitted
8 Jul 2022
Last updated
26 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 420 mg EG1206A EirGenix Pertuzumab in 14 mL Injection, Perjeta (EU origin) 420 mg in 14 mL Injection and Perjeta (US origin) 420 mg in 14 mL Injection in people with Breast Cancer, run by EirGenix, Inc. at 1 site in Germany.

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 10 inclusion and 44 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 26 Jan 2023. 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 Germany. 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-inf of pertuzumab (time frame: Pre-dose to day 91, 21 timepoints). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05471648.

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 26 Jan 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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