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Sym004 Versus Futuximab or Modotuximab in Patients With mCRC

NCT03549338 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-09-28

Study results available
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Summary

This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (anti-EGFR) mAb therapy. The study is designed to evaluate the relative antitumor activity of each agent as assessed by imaging studies performed after 8 weeks of treatment.

Conditions

Interventions

DRUG

Sym004

Sym004 is a 1:1 mixture of two recombinant mAbs (futuximab and modotuximab) which bind specifically to non-overlapping epitopes located in the extracellular domain (ECD) of the EGFR.

DRUG

Futuximab

Futuximab is one of two mAb components that constitute Sym004.

DRUG

Modotuximab

Modotuximab is one of two mAb components that constitute Sym004.

Sponsors & Collaborators

  • Symphogen A/S

    lead INDUSTRY

Principal Investigators

  • Scott Kopetz, MD,PhD,FACP · The University of Texas MD Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2019-03-01
Completion
2019-03-09
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549338 on ClinicalTrials.gov