RPH-051

RPH-051 is a monoclonal antibody developed by R-Pharm. Its target is HER2 (the sponsor names HER2). The sponsor states: A pertuzumab biosimilar candidate, a HER2-targeted monoclonal antibody given with trastuzumab and docetaxel, being tested for non-inferiority and comparability of safety/immunogenicity against reference product Perjeta. ClinicalTrials.gov describes the intervention as: RPH-051: concentrate for solution for infusion, 30 mg/mL 14 mL of the liquid concentrate is diluted with 250 mL of 0.9% sodium chloride solution. The nominal concentration of the prepared solution is 3.0 mg/mL for the loading dose and 1.6 m. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT07386938 (A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer), in HR-positive / HER2-negative breast cancer and HER2-positive breast cancer. The largest, NCT07386938, plans to enrol 246 participants with primary completion expected 2025-10-15. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.