Study Objective and Background
A bioequivalence study was conducted for pharmacokinetic and immunogenicity assessments of Pertuzumab 420 mg solution for infusion, administered as a single intravenous dose. This was a single-dose, parallel-group study in healthy male participants. Subjects received either the test or reference product as a 420 mg intravenous infusion.
Molecule Overview
Pertuzumab inhibits HER2 receptor dimerization, slowing or halting tumour cell growth. Pertuzumab 420 mg is indicated for HER2-positive breast cancer and is used with trastuzumab and chemotherapy in:
- Neoadjuvant and adjuvant early breast cancer settings where recurrence risk is high
- Metastatic breast cancer in patients without prior anti-HER2 therapy
Services Provided by Lambda
| Protocol development |
| Clinical study conduct (Screening, Housing, Dosing, Sample collection & study close-out) |
| Stratification-Based Randomization Using IWRS |
| Clinical Data Management |
| Bioanalysis (PK & Immunogenicity) |
| PK/Statistical analysis |
| Clinical Study Report (CSR) preparation |
| Dossier preparation for regulatory submission |
Study Highlights
| Double-blind design |
| Infusion administered over 60 minutes using a volumetric pump |
| Objectives: compare PK, immunogenicity, and safety between test and reference products |
| Safety checks conducted at scheduled intervals, including injection site assessments |
| Total ambulatory samples collected: 12 |
Safety Criteria
| Screening included clinical examination, ECG, chest X-ray, cardiac markers, TMT, 2D echo, and comprehensive laboratory tests. |
| Dosing was overseen by a qualified physician with monitoring for up to 48 hours post-dose. |
| Cardiac monitoring continued throughout the infusion period. |
Study Execution
The study was executed in multiple groups in accordance with the protocol and requirements. All challenges and anticipated risks were addressed through effective planning and proactive measures.
| Challenge | Solution Implemented |
|---|---|
| Long study duration (3 months) with multiple ambulatory visits for 135 participants | Visit schedules were planned in advance with reminder outreach and onsite coordination. A coordinated scheduling approach and a dedicated team helped avoid overlaps and maintain compliance. |
| Stringent selection parameters including cardiac markers, TMT, 2D echo, and other clinical checks | A structured screening workflow supported timely assessments and accurate selection of eligible participants. |
| Continuous observation during confinement to ensure participant safety | Trained clinical staff followed predefined safety procedures for ongoing monitoring and prompt follow up. No SAE reported. |
Conclusion
The study was completed within planned timelines, supported by organised operations, consistent oversight, and coordinated execution across all activities.
Reference
• Prescribing Information – Pertuzumab (420 mg solution for infusion), Revised 01/2020.
About Early Phase Capabilities – Lambda Therapeutic Research
With 25 years of legacy, Lambda Therapeutic Research, a trusted full-service CRO, brings unmatched expertise in early phase development with a track record of completing over 8,000 PK/PD studies. Our highly specialized team, comprising global experts in early phase development and clinical pharmacology, meticulously designs integrated early-phase programs. We conduct a wide array of studies, including first-in-human (FIH), proof-of-concept, bioavailability/bioequivalence (BA/BE), drug-drug interaction (DDI), biosimilar, pharmacokinetic (PK), and single ascending dose/multiple ascending dose (SAD/MAD) studies. With advanced facilities, operational expertise, and vast development experience, we ensure precise execution of trials involving both patients and healthy volunteers, enabling informed decisions and successful outcomes for your drug development journey.
Lambda excels in providing comprehensive services vital for successful clinical studies supporting biosimilar marketing applications. Developing biological products is a rigorous process due to their complex protein-based molecular structure, with molecular weights ranging from 3,000 to 150,000 Daltons. This category includes Growth Hormones, Insulin, Monoclonal Antibodies (MABs), and more. Unlike chemically derived products, biosimilars require specialized assessments of Pharmacodynamic and Immunogenicity, in addition to Pharmacokinetic evaluations. Our specialized expertise is essential for the successful clinical development of these products. Our expertise ranges from PK bioequivalence to evaluating the similarity of effects in patients. Years of analyzing drug bioequivalence and bioavailability have honed our capabilities to craft precise comparative studies, establishing biosimilarity with marketed reference drugs.
Connect with our experts at BD@lambda-cro.com to leverage the extensive end-to-end capabilities of Lambda Therapeutic Research & Novum Pharmaceutical Research Services
