Sym004 in Metastatic Colorectal Cancer and ECD-EGFR Patients

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)

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02965417

Enrollment

Registered

2016-11-16

Start date

2016-12-31

Completion date

2017-01-31

Last updated

2017-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Colorectal Cancer

Keywords

Resistance to anti-EGFR monoclonal antibodies, Mutation of ECD-EGFR

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).

Interventions

DRUGSym004

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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion and

Exclusion criteria

have been removed due to Symphogen's business decision to no longer perform the clinical study.

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026