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NCT02965417 Clinical Trial

Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

Metastatic Colorectal Cancer Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02965417
Other study ID # Sym004-11
Secondary ID 2016-000621-39
Status Withdrawn
Phase Phase 2
First received November 14, 2016
Last updated January 31, 2017
Start date December 2016
Est. completion date January 2017

Study information
Verified date January 2017
Source Symphogen A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Sym004
Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Symphogen A/S

Outcome
Type Measure Description Time frame Safety issue
Primary Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 1 year
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