RPH-030 vs Vectibix Phase 1 mCRC Trial Pharmacokinetics Study
Summary
NIH registered a Phase 1 clinical trial (NCT07543744) comparing the pharmacokinetics, safety, and immunogenicity of RPH-030 versus Vectibix® in patients with metastatic colorectal cancer harboring wild-type RAS genes, administered as first-line therapy alongside FOLFIRI. The single-center trial targets a population with an unmet therapeutic need given the established efficacy of anti-EGFR agents in RAS wild-type mCRC. Trial details are publicly accessible via ClinicalTrials.gov.
“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.”
About this source
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What changed
A Phase 1 clinical trial registration (NCT07543744) was added to ClinicalTrials.gov under NIH authority, documenting a comparative pharmacokinetic, safety, and immunogenicity study of RPH-030 and Vectibix® in metastatic colorectal cancer patients with wild-type RAS genes. The trial will evaluate these agents in combination with FOLFIRI as first-line therapy. This registration represents standard clinical trial disclosure requirements rather than a regulatory action imposing compliance obligations. Pharmaceutical manufacturers and clinical investigators should note this biosimilar/biobetter development activity in the anti-EGFR mCRC space.
Archived snapshot
Apr 23, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Phase 1 NCT07543744 Kind: PHASE1 Apr 22, 2026
Abstract
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.
Conditions: Metastatic Colorectal Cancer
Interventions: RPH-030, Vectibix®, Irinotecan, Calcium Folinate, Fluorouracil
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