# RPH-051

Source: https://onco.cc/drugs/rph-051/  
OnCo record `rph-051` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of RPH-051: https://clinicaltrials.gov/search?intr=RPH-051

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- targets: [HER2](https://onco.cc/targets/her2/)
- trials: [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](https://onco.cc/trials/nct07386938/)
- companies: [R-Pharm](https://onco.cc/companies/r-pharm/)

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JSON: https://onco.cc/api/v1/entities/rph-051.json