{"entity":{"id":"rph-051","kind":"drug","name":"RPH-051","aka":[],"tldr":"RPH-051 is an experimental monoclonal antibody from R-Pharm in phase 3 trials for HR-positive / HER2-negative breast cancer and HER2-positive breast cancer, aimed at HER2.","summary":"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 was scheduled for 2025-10-15 on the registry. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of RPH-051","url":"https://clinicaltrials.gov/search?intr=RPH-051"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","breast-her2-positive"],"sections":[],"technologies":[],"targets":["her2"],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct07386938"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"modality":"monoclonal antibody","mechanism":"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.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/rph-051/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"trial":[{"id":"nct07386938","kind":"trial","name":"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","route":"/trials/nct07386938/"}],"company":[{"id":"r-pharm","kind":"company","name":"R-Pharm","route":"/companies/r-pharm/"}]}}