Compare subcutaneous delivery methods for trastuzumab in healthy men.
A Phase 1, Randomized, Two-Part, Parallel-Group Study to Assess the Bioequivalence of Subcutaneously Administered Trastuzumab Via Different Subcutaneous Delivery Platforms in Healthy Male Subjects
We will test whether a handheld syringe/syringe pump with infusion set and an on-body delivery system deliver similar amounts of trastuzumab and are safe in healthy men.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Drugs / interventions | pertuzumab, trastuzumab |
| Locations | 4 sites (Anaheim, California and 3 other locations) |
| Trial ID | NCT07214766 on ClinicalTrials.gov |
What this trial studies
This two-part Phase 1 trial gives a single subcutaneous dose of trastuzumab to healthy male volunteers to compare pharmacokinetics, safety, and tolerability across two delivery platforms. Participants are randomized to receive trastuzumab via a handheld syringe/syringe pump with an infusion set or via an on-body delivery system, and blood samples will be taken over time to measure drug levels. Screening requires normal cardiac function (LVEF ≥55%), negative infectious disease tests, BMI 18–38 with weight ≤100 kg, and agreement to contraception, and subjects with significant medical histories or prior severe antibody hypersensitivity are excluded. Safety monitoring includes adverse event reporting and cardiac assessment, and the primary aim is to establish bioequivalence between the delivery methods.
Who should consider this trial
Good fit: Ideal candidates are healthy adult men who meet BMI and weight limits, have normal cardiac function and negative infectious screens, and have no significant medical conditions or history of antibody hypersensitivity.
Not a fit: People with a history of moderate-to-severe allergic reactions to monoclonal antibodies, significant medical comorbidities, cardiac dysfunction, or women and children will not benefit because they are excluded from this healthy-male Phase 1 study.
Why it matters
Potential benefit: If the devices are bioequivalent and well tolerated, this could allow more convenient and potentially at-home subcutaneous options for delivering trastuzumab to patients.
How similar studies have performed: Subcutaneous formulations of trastuzumab and on-body delivery systems for biologic drugs have previously shown comparable pharmacokinetics and improved convenience in other studies and approvals.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Within body mass index (BMI) range 18 to 38 kilogram per meter square (kg/m2), inclusive. Body weight \<=100 kg * Left ventricular ejection fraction (LVEF) \>= 55 percent (%) measured by echocardiogram (ECHO) * Negative test result for drugs of abuse * Negative test result for hepatitis B surface antigen, hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody screen * Negative test for latent Tuberculosis (TB) infection by QuantiFERON® TB Gold * Agree to use contraception and will refrain from sperm donation Exclusion Criteria: * Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, respiratory, gastrointestinal, immunological, neurological, or psychiatric disorder; acute infection; or other unstable medical disease * History of moderate or severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins * Known sensitivity to recombinant hyaluronidase or other form of hyaluronidase * History or presence of atrial fibrillation * History of any clinically significant or clinically relevant cardiac condition * History or presence of clinically significant electrocardiogram (ECG) abnormalities * History of uncontrolled hypertension, hyperlipidemia, thyroid disorder, or diabetes * Family history of clinically significant and clinically relevant hypersensitivity, allergy, or severe cardiac diseases * History of previous anti-cancer treatments including pertuzumab, trastuzumab, anthracyclines, or any cardiotoxic drugs * History of active or latent TB, regardless of treatment history * Poor peripheral venous access * History or presence of any malignancy, with the exception of completely excised basal cell or squamous cell carcinoma of the skin
Where this trial is running
Anaheim, California and 3 other locations
- Anaheim Clinical Trials — Anaheim, California, United States (Recruiting)
- Daytona Beach Clinical Rsch Unit — Daytona Beach, Florida, United States (Recruiting)
- QPS Bio-Kinetic — Springfield, Missouri, United States (Recruiting)
- Fortrea Clinical Research Unit - Dallas — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: GP44770 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.