Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients
Sponsor
Symphogen A/S (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02965417
Collaborator
(none)
0
1
1
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date
:
Dec 1, 2016
Actual Primary Completion Date
:
Jan 1, 2017
Actual Study Completion Date
:
Jan 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sym004 All patients will receive a loading dose of Sym004, followed by weekly (q1w) infusions |
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).
|
Outcome Measures
Primary Outcome Measures
- Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [1 year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion and Exclusion criteria have been removed due to Symphogen's business decision to no longer perform the clinical study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Symphogen A/S
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Symphogen A/S
ClinicalTrials.gov Identifier:
NCT02965417
Other Study ID Numbers:
- Sym004-11
- 2016-000621-39
First Posted:
Nov 16, 2016
Last Update Posted:
Feb 1, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Symphogen A/S
Additional relevant MeSH terms: