Breast CancerPhase 1NCT07861139
Comparative Study of QL1209 and Perjeta® in Healthy Male Participants
A Phase 1 study testing QL1209 and US-Perjeta® in people with Breast Cancer, run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male participants. 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?
- QL1209 and US-Perjeta®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 male participants aged 18-55 (inclusive);
- Participants with body weight of ≥50 kg (inclusive)) and body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive);
- Participants who voluntarily sign the written ICF;
- Participants who are able to communicate well with the investigator and complete the study as per the study protocol;
- Male participants who agree to use reliable contraceptives (such as abstinence, contraceptive barrier, sterilization surgery) for themselves and their partners (such as birth control pills, contraceptive barrier, injection of the contraceptive medroxyprogesterone acetate or contraception by subcutaneous implantation), and agree not to donate sperm, during the study and within 7 months after infusion of the investigational product.
Who cannot join
- Trial participants with a history of or currently having any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematological, immunological, psychiatric and metabolic disorders, or any other diseases that may interfere with the study results, or participants with clinically significant allergic reactions or allergic constitution, angioedema, interstitial pneumonitis or acute respiratory distress syndrome;
- Participants with abnormal vital signs (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; heart rate < 50 bpm or > 100 bpm) or clinically significant abnormalities in physical examination, ECG and laboratory tests (participant to the judgment of clinicians), and those whose LVEF is beyond the normal range as shown by echocardiography; Adult males with a left ventricular ejection fraction (LVEF) outside the normal reference range of 52% to 72%, as defined by the American Society of Echocardiography (ASE), will be excluded;
- Any clinically relevant laboratory findings that, in the opinion of the Investigator, would preclude inclusion in the trial; including alanine aminotransferase (ALT) >1.1 × upper limit of normal (ULN), aspartate aminotransferase (AST) >1.2 × ULN, bilirubin (total) >1.5 × ULN. Participants with estimated glomerular filtration rate (eGFR) based on Cockcroft-Gault equation < 90 mL/min/1.73 m2 will be excluded. If any of these tests are out-of-range, the tests can be repeated once;
- QT interval corrected for heart rate using Fridericia's correction (QTcF) > 450 msec.
- Participants with poor venous access;
- Participants with a history of allergy to the investigational product (pertuzumab or any of its excipients), or, significant allergy to food, or other substances;
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- Participants treated with anti-HER2 therapy or any antibody or other protein drug targeting the HER2 receptor;
- Participants who have taken any prescription or OTC drugs, including any herbal, and/or nutritional supplements (e.g. vitamins, mineral supplements or other health products) within 14 days before screening;
- Use of any monoclonal antibody within 3 months or 5 half-lives (whichever is longer) before administration;
- Use of investigational drugs within 30 days or 5 half-lives (whichever is longer) or discontinuation of monoclonal antibodies with unknown half-life within 6 months; prior to scheduled administration of the investigational drugs on Day 1 of this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Single-Dose, Parallel-Controlled Clinical Study to Compare the Pharmacokinetic Similarity Between QL1209 (Perjeta® Biosimilar Candidate) and Perjeta® (Pertuzumab) in Healthy Male Participants
The goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male participants.
Participants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on D1, followed by observation until Day 99 postdose for PK, safety and immunogenicity assessments.
Read the detailed description
This is a randomized, double-blind, single-dose, parallel-controlled clinical trial to compare the PK profile of QL1209 and Perjeta® in healthy male participants. It is planned to enroll 80 healthy male participants and randomize them into the test group or reference group at a ratio of 1:1.
Participants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on Day 1, followed by observation until Day 99 post-dose for PK, safety and immunogenicity assessments.
The study will include a screening period from Day 28 to Day 1. The participants will be admitted to the clinical study site on Day 1 and receive the QL1209 or US-Perjeta® on Day 1. The participants will remain in the in-patient department for observation until the assessment on Day 3 is completed. Participants will return to the clinical study site for out-patient visits till Day 99 or upon early withdrawal.
In the study, validated test methods will be used to determine QL1209/Pertuzumab concentrations in PK samples at different visit points after infusion administration. Non- compartmental models will be used to calculate PK parameters and perform statistical analysis. Anti-drug antibody (ADA) and titer in immunogenicity samples will be determined using a validated test method, and neutralizing antibody (Nab) will be further tested for ADA-positive samples.
- Conditions
- Breast Cancer
- Being tested
- QL1209, US-Perjeta®
- Keywords
- Comparative Pharmacokinetic, QL2109, Perjeta
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1209Drug
A single intravenous infusion of QL1209 420 mg for 60 min ± 10 min.
US-Perjeta®Drug
A single intravenous infusion of US-Perjeta® 420 mg for 60 min ± 10 min.
| Study group | Role | What they receive |
|---|---|---|
| QL1209 | Experimental | Not described Receives: Drug: QL1209 |
| US-Perjeta® | Active comparator | Not described Receives: Drug: US-Perjeta® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
Area under the serum concentration-time curve from time 0 to infinity
Measured: up to 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
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.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861139
- Sponsor's protocol ID
- QL1209-102
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Single-Dose, Parallel-Controlled Clinical Study to Compare the Pharmacokinetic Similarity Between QL1209 (Perjeta® Biosimilar Candidate) and Perjeta® (Pertuzumab) in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT07861139
- Acronym / sponsor ID
- QL1209-102
- Conditions
- Breast Cancer
- Keywords
- Comparative Pharmacokinetic, QL2109, Perjeta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Oct 2026 (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 goal of this clinical trial is to evaluate the similarity of pharmacokinetic (PK) parameters following a single intravenous infusion of QL1209 (Perjeta® biosimilar candidate) and Perjeta® (Pertuzumab) in healthy male participants.
Participants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on D1, followed by observation until Day 99 postdose for PK, safety and immunogenicity assessments.
Detailed description
This is a randomized, double-blind, single-dose, parallel-controlled clinical trial to compare the PK profile of QL1209 and Perjeta® in healthy male participants. It is planned to enroll 80 healthy male participants and randomize them into the test group or reference group at a ratio of 1:1.
Participants will receive a single intravenous infusion of QL1209 or US-Perjeta® 420 mg on Day 1, followed by observation until Day 99 post-dose for PK, safety and immunogenicity assessments.
The study will include a screening period from Day 28 to Day 1. The participants will be admitted to the clinical study site on Day 1 and receive the QL1209 or US-Perjeta® on Day 1. The participants will remain in the in-patient department for observation until the assessment on Day 3 is completed. Participants will return to the clinical study site for out-patient visits till Day 99 or upon early withdrawal.
In the study, validated test methods will be used to determine QL1209/Pertuzumab concentrations in PK samples at different visit points after infusion administration. Non- compartmental models will be used to calculate PK parameters and perform statistical analysis. Anti-drug antibody (ADA) and titer in immunogenicity samples will be determined using a validated test method, and neutralizing antibody (Nab) will be further tested for ADA-positive samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1209 | Experimental | Drug: QL1209 |
| US-Perjeta® | Active comparator | Drug: US-Perjeta® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male participants aged 18-55 (inclusive);
- Participants with body weight of ≥50 kg (inclusive)) and body mass index (BMI) of 18.5-32.0 kg/m2 (inclusive);
- Participants who voluntarily sign the written ICF;
- Participants who are able to communicate well with the investigator and complete the study as per the study protocol;
- Male participants who agree to use reliable contraceptives (such as abstinence, contraceptive barrier, sterilization surgery) for themselves and their partners (such as birth control pills, contraceptive barrier, injection of the contraceptive medroxyprogesterone acetate or contraception by subcutaneous implantation), and agree not to donate sperm, during the study and within 7 months after infusion of the investigational product.
Key exclusion criteria (10 listed)
- Trial participants with a history of or currently having any clinically significant diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematological, immunological, psychiatric and metabolic disorders, or any other diseases that may interfere with the study results, or participants with clinically significant allergic reactions or allergic constitution, angioedema, interstitial pneumonitis or acute respiratory distress syndrome;
- Participants with abnormal vital signs (systolic blood pressure < 90 mmHg or > 140 mmHg, diastolic blood pressure < 50 mmHg or > 90 mmHg; heart rate < 50 bpm or > 100 bpm) or clinically significant abnormalities in physical examination, ECG and laboratory tests (participant to the judgment of clinicians), and those whose LVEF is beyond the normal range as shown by echocardiography; Adult males with a left ventricular ejection fraction (LVEF) outside the normal reference range of 52% to 72%, as defined by the American Society of Echocardiography (ASE), will be excluded;
- Any clinically relevant laboratory findings that, in the opinion of the Investigator, would preclude inclusion in the trial; including alanine aminotransferase (ALT) >1.1 × upper limit of normal (ULN), aspartate aminotransferase (AST) >1.2 × ULN, bilirubin (total) >1.5 × ULN. Participants with estimated glomerular filtration rate (eGFR) based on Cockcroft-Gault equation < 90 mL/min/1.73 m2 will be excluded. If any of these tests are out-of-range, the tests can be repeated once;
- QT interval corrected for heart rate using Fridericia's correction (QTcF) > 450 msec.
- Participants with poor venous access;
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 |
|---|---|---|
| QL1209A single intravenous infusion of QL1209 420 mg for 60 min ± 10 min. | Drug | QL1209 |
| US-Perjeta®A single intravenous infusion of US-Perjeta® 420 mg for 60 min ± 10 min. | Drug | US-Perjeta® |
Primary outcome
AUC0-∞
Time frame: up to 99 days
Area under the serum concentration-time curve from time 0 to infinity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL1209 and US-Perjeta® in people with Breast Cancer, run by Qilu Pharmaceutical Co., Ltd..
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Monroe, MD (240-673-0500 ext. 1716, anne.monroe@pharmaron-us.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-∞ (time frame: up to 99 days). 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 9 Oct 2026.