Back to resultsSym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients
Primary Purpose
Metastatic Colorectal Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Sym004
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Resistance to anti-EGFR monoclonal antibodies, Mutation of ECD-EGFR
Eligibility Criteria
Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sym004
Arm Description
All patients will receive a loading dose of Sym004, followed by weekly (q1w) infusions
Outcomes
Primary Outcome Measures
Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02965417
Brief Title
Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients
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)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Symphogen made a business decision to no longer perform the clinical study.
Study Start Date
December 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Symphogen A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
Resistance to anti-EGFR monoclonal antibodies, Mutation of ECD-EGFR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sym004
Arm Type
Experimental
Arm Description
All patients will receive a loading dose of Sym004, followed by weekly (q1w) infusions
Intervention Type
Drug
Intervention Name(s)
Sym004
Intervention Description
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).
Primary Outcome Measure Information:
Title
Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients
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