Clinical Trials/NCT02965417

NCT02965417WithdrawnPhase 2

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)

Symphogen A/S0 sitesStarted: December 2016Last updated: February 1, 2017

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 2
Status: Withdrawn
Sponsor: Symphogen A/S
Primary Endpoint: Best overall response (OR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

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).

Study Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Sym004

Experimental

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

Intervention: Sym004 (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 1 year

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor

Symphogen A/S

Sponsor Class

Industry

Responsible Party

Sponsor

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