Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

NCT ID: NCT02965417

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sym004

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

Group Type EXPERIMENTAL

Sym004

Intervention Type DRUG

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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symphogen A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2016-000621-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Sym004-11

Identifier Type: -

Identifier Source: org_study_id

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