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Clinical Trials/NCT02965417
NCT02965417
Withdrawn
Phase 2

An Open-label, Multicenter, Phase 2 Trial Investigating Sym004 in Patients With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies and Documented Mutation of Extra Cellular Domain of EGFR (ECD-EGFR)

Symphogen A/S0 sitesDecember 2016
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ConditionsMetastatic Colorectal Cancer
InterventionsSym004
DrugsSym004

Overview

Phase
Phase 2
Intervention
Sym004
Conditions
Metastatic Colorectal Cancer
Sponsor
Symphogen A/S
Primary Endpoint
Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Status
Withdrawn
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

This is a single arm, phase 2, open-label, multicenter trial in patients with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs) and documented mutation of extra cellular domain EGFR (ECD-EGFR).

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Sym004

All patients will receive a loading dose of Sym004, followed by weekly (q1w) infusions

Intervention: Sym004

Outcomes

Primary Outcomes

Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time Frame: 1 year

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