NCT02083653

Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Sym004 Doses Versus Investigator's Choice (Best Supportive Care, Capecitabine, 5-FU) in Subjects With Metastatic Colorectal Cancer and Acquired Resistance to Anti-EGFR Monoclonal Antibodies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Symphogen A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This trial assesses the efficacy of two different weekly dosing regimens of Sym004 (Arm A: 12 mg/kg/week versus Arm B: 9 mg/kg loading dose followed by 6 mg/kg/week) compared with investigator's choice in terms of overall survival time in subjects with mCRC. Subjects assigned to Arm C will receive best supportive care (BSC), Fluorouracil (5-FU), or Capecitabine, per local standard of care. Subjects will receive treatment until unacceptable toxicity, disease progression, withdrawal of consent, or until the subject meets any of the criteria for treatment discontinuation or trial discontinuation. Therefore, the duration of treatment will differ among individuals and cannot be fixed in advance.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-06
• Primary completion: 2016-10-24
• Completion: 2017-04-26
• First posted: 2014-03-11
• Last updated: 2019-04-16
• Results posted: 2018-12-24

Locations

54 sites across 10 countries: United States, Austria, Belgium, France, Germany, Hungary, Italy, Poland, Russia, Spain

Regulatory

• FDA-regulated drug study