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Erbitux (Cetuximab)

DRUG5 trials

Sponsors

Eli Lilly and Company, Merck KGaA, Darmstadt, Germany, Gruppo Oncologico Italia Meridionale, University of Campania Luigi Vanvitelli, HC Biopharma Inc.

Conditions

BioequivalenceCetuximabColorectal NeoplasmsHealthy VolunteersMetastases, NeoplasmMetastatic Colorectal Cancer (CRC)Metastatic Colorectal Cancer (mCRC)Pharmacokinetics

Phase 1

A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
RecruitingNCT07813468
HC Biopharma Inc.Bioequivalence, Cetuximab, Healthy Volunteers +1
Start: 2026-09-05End: 2027-06-30Target: 92Updated: 2026-09-10

Phase 2

Study of Erbitux (Cetuximab) in Patients With Metastatic Colorectal Carcinoma
CompletedNCT00044863
Eli Lilly and CompanyColorectal Neoplasms, Metastases, Neoplasm
Start: 2002-08-31End: 2005-12-31Updated: 2011-02-23
ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer"
RecruitingNCT07381764
Gruppo Oncologico Italia MeridionaleMetastatic Colorectal Cancer (CRC)
Start: 2026-03-20End: 2031-03-30Target: 150Updated: 2026-09-11

Phase 3

Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer
RecruitingNCT07389265
University of Campania Luigi VanvitelliMetastatic Colorectal Cancer (mCRC)
Start: 2025-10-01End: 2030-10-01Target: 480Updated: 2026-02-05

Unknown Phase

A Korean Post-marketing Surveillance Study on Erbitux® in Patients With Metastatic Colorectal Cancer Refractory to Irinotecan-containing Treatment
CompletedNCT01082315
Merck KGaA, Darmstadt, GermanyColorectal Neoplasms
Start: 2009-04-30End: 2014-07-31Updated: 2014-08-29