Clinical Trial

A Comparative Study of Pharmacokinetics, Safety, and Immunogenicity of RPH-030 and Vectibix® in Patients With Metastatic Colorectal Cancer With Wild-type RAS as First-line Therapy in Combination With FOLFIRI

Recruiting Phase 1
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Record status
This record was last updated April 22, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
The primary objective of this study is to demonstrate equivalence of pharmacokinetic properties, and comparability of safety and immunogenicity parameters of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI. The additional objective is to perform a pilot evaluation of the efficacy of RPH-030 and Vectibix® following a single (first) intravenous administration to patients with mCRC with wild-type RAS genes as 1-line therapy in combination with FOLFIRI.
Trial Details
NCT Number NCT07543744
Lead Sponsor R-Pharm
Conditions Metastatic Colorectal Cancer
Enrollment 180 participants
Start Date 2025-04-17
Primary Completion 2026-05-15 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-22