Breast CancerPhase 1NCT06886659
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
A Phase 1 study testing Trastuzumab (proposed Trastuzumab biosimilar) and Herclon in people with Breast Cancer and Breast Neoplasms, run by Incepta Pharmaceuticals Ltd at 2 sites in Bangladesh.
Trial summary
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. 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, Breast Neoplasms, Breast Disease
- What is being tested?
- Trastuzumab (proposed Trastuzumab biosimilar) and Herclon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesBangladesh
- Study dates
- 23 Jan 2024to 28 Dec 2024
- 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
- Healthy adult male participant, age 18 to 55 years old
- BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
- Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
- Able to understand procedure, agree to participate and willing to give informed consent.
- Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
- Male subjects, if married, must agree that they and their spouse will use adequate contraception or be of non-childbearing potential.
Who cannot join
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
- History of and/or current cardiac disease
- Neutrophil count less than the lower limit of normal range during screening.
- A positive hepatitis screen (includes subtypes B \& C).
- Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
- History of any cancer, including carcinoma in situ
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- Volunteer with history of angina, dyspnea, orthopnea, congestive heart failure or myocardial infarction
- Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
- History or evidence of drug abuse or of alcoholism or of moderate alcohol use.
Trial locations and contacts
2 sites in 1 country.
Bangladesh2 sites
Al-Manar Hospital Ltd,
Dhaka, 1207
Universal Medical College
Dhaka, 1215
About this study
Official title: A Randomized, Double Blind, Parallel, Active Controlled Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta With Trastuzumab (Roche) in Healthy, Adult Subjects by Single IV Infusion Under Fasting Condition
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. HER2 regulate cell growth and survival, as well as adhesion, migration, differentiation and other cellular response. But when HER2 signaling is over expressed it causes uncontrolled cell growth which leads to the formation of cancerous tumor.
Read the detailed description
In this study, healthy adult male volunteers will receive a single intravenous administration of Trastuzumab (Incepta) or Trastuzumab (Roche) according to randomization. During the course of the study, the pharmacokinetics will be assessed by sampling the levels of the drug in the blood and by comparing these levels among the different administration arms. Safety and immunologic response will also be evaluated throughout the study.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Being tested
- Trastuzumab (proposed Trastuzumab biosimilar), Herclon
- Keywords
- Biosimilarity, Bioequivalence, Tastuzumab, Healthy male volunteers, PK
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab (proposed Trastuzumab biosimilar)Drug
Also called Test Product
6 mg/kg single intravenous infusion of Trastuzumab of Incepta Pharmaceuticals Ltd
HerclonDrug
Also called Reference Product
6 mg/kg single intravenous infusion of Trastuzumab of Roche
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab (proposed Trastuzumab biosimilar) | Experimental | 40 healthy adult male will get Trastuzumab 150 mg/vial manufactured by Incepta Pharmaceuticals Ltd. Receives: Drug: Trastuzumab (proposed Trastuzumab biosimilar) |
| Herclon | Active comparator | 40 healthy adult male will get Herclon 150 mg/vial manufactured by Roche. Receives: Drug: Herclon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum Observed Drug Concentration In Plasma
Measured: 71 days from the starting of infusion
AUC0-t
Area Under The Concentration Versus Time Curve Up To The Last Measurable Time Point
Measured: 71 days from the starting of infusion
AUC0-inf
Area Under The Concentration Versus Time Curve From Time 0 To Infinity
Measured: 71 days from the starting of infusion
Safety assessment: The number of adverse events will be evaluated and compared between the reference and test drugs groups.
No of adverse events in both reference and test product arm will be assessed and compared by monitoring the presence of any AEs or SAEs throughout the study period.
Measured: 71 days from the starting of infusion
Immunogenicity assessment: Immunogenicity will be assessed by measuring Anti-Drug Antibodies (ADA) formation.
The incidence of Anti-Drug Antibodies (ADA) formation will be measured by taking blood samples on before treatment (pre-dose) and and on day 71
Measured: 71 days from the starting of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start23 Jan 2024
- Primary completion28 Dec 2024
- Study completion28 Dec 2024
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
- Model description
- Participants will be assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group will be randomized.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incepta Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EskeGen Ltd, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Manindranath Roy, Principal investigator, Professor (Biochemistry) United Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886659
- Sponsor's protocol ID
- 2022/TR/P-I/01
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: By publication in the journal
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Parallel, Active Controlled Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta With Trastuzumab (Roche) in Healthy, Adult Subjects by Single IV Infusion Under Fasting Condition
- ClinicalTrials.gov ID
- NCT06886659
- Acronym / sponsor ID
- 2022/TR/P-I/01
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Disease, Antineoplastic Agents
- Keywords
- Biosimilarity, Bioequivalence, Tastuzumab, Healthy male volunteers, PK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Incepta Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Collaborators
- EskeGen Ltd, Bangladesh
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 20 Mar 2025 (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.
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. HER2 regulate cell growth and survival, as well as adhesion, migration, differentiation and other cellular response. But when HER2 signaling is over expressed it causes uncontrolled cell growth which leads to the formation of cancerous tumor.
Detailed description
In this study, healthy adult male volunteers will receive a single intravenous administration of Trastuzumab (Incepta) or Trastuzumab (Roche) according to randomization. During the course of the study, the pharmacokinetics will be assessed by sampling the levels of the drug in the blood and by comparing these levels among the different administration arms. Safety and immunologic response will also be evaluated throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned to one of the treatment arms at the beginning of the trial and continue in that arm throughout the length of the trial. Assignment to a group will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab (proposed Trastuzumab biosimilar) | Experimental | Drug: Trastuzumab (proposed Trastuzumab biosimilar)40 healthy adult male will get Trastuzumab 150 mg/vial manufactured by Incepta Pharmaceuticals Ltd. |
| Herclon | Active comparator | Drug: Herclon40 healthy adult male will get Herclon 150 mg/vial manufactured by Roche. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy adult male participant, age 18 to 55 years old
- BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
- Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
- Able to understand procedure, agree to participate and willing to give informed consent.
- Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
Key exclusion criteria (9 listed)
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
- History of and/or current cardiac disease
- Neutrophil count less than the lower limit of normal range during screening.
- A positive hepatitis screen (includes subtypes B \& C).
- Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
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 |
|---|---|---|
| Trastuzumab (proposed Trastuzumab biosimilar)Also: Test Product6 mg/kg single intravenous infusion of Trastuzumab of Incepta Pharmaceuticals Ltd | Drug | Trastuzumab (proposed Trastuzumab biosimilar) |
| HerclonAlso: Reference Product6 mg/kg single intravenous infusion of Trastuzumab of Roche | Drug | Herclon |
Primary outcome
Cmax
Time frame: 71 days from the starting of infusion
Maximum Observed Drug Concentration In Plasma
AUC0-t
Time frame: 71 days from the starting of infusion
Area Under The Concentration Versus Time Curve Up To The Last Measurable Time Point
AUC0-inf
Time frame: 71 days from the starting of infusion
Area Under The Concentration Versus Time Curve From Time 0 To Infinity
Safety assessment: The number of adverse events will be evaluated and compared between the reference and test drugs groups.
Time frame: 71 days from the starting of infusion
No of adverse events in both reference and test product arm will be assessed and compared by monitoring the presence of any AEs or SAEs throughout the study period.
Immunogenicity assessment: Immunogenicity will be assessed by measuring Anti-Drug Antibodies (ADA) formation.
Time frame: 71 days from the starting of infusion
The incidence of Anti-Drug Antibodies (ADA) formation will be measured by taking blood samples on before treatment (pre-dose) and and on day 71
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. By publication in the journal
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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.
Manindranath Roy principal investigator
Professor (Biochemistry) United Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trastuzumab (proposed Trastuzumab biosimilar) and Herclon in people with Breast Cancer and Breast Neoplasms, run by Incepta Pharmaceuticals Ltd at 2 sites in Bangladesh.
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 6 inclusion and 9 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bangladesh. 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?
Cmax (time frame: 71 days from the starting of infusion). The study lists 5 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 22 Jul 2025.