MedTrace Logo

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

NCT02083653 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2019-04-16

Study results available
· View outcomes & findings →

Summary

This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAbs).

Conditions

Interventions

DRUG

Sym004 (12 mg/kg)

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

DRUG

Sym004 (9/6 mg/kg)

Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.

OTHER

Best Supportive Care (BSC)

BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.

DRUG

Fluorouracil (5-FU)

5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

DRUG

Capecitabine

Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.

Sponsors & Collaborators

  • Symphogen A/S

    lead INDUSTRY

Principal Investigators

  • Josep Tabernero, MD, PhD · Vall d'Hebron University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-06
Primary Completion
2016-10-24
Completion
2017-04-26
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
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 NCT02083653 on ClinicalTrials.gov