Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2017-04-26
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S
• Treatments: Antibodies, Monoclonal; Capecitabine; Fluorouracil

Criteria

Inclusion Criteria:

• Written informed consent obtained before undergoing any study-related activities

• Male or female, at least 18 years of age

• Subjects with histologically or cytologically confirmed mCRC, Kirsten rat sarcoma wild-type (KRAS WT) at initial diagnosis

• Failure of or intolerance to 5-FU, Oxaliplatin, and Irinotecan

• Acquired resistance to marketed anti-EGFR mAbs as defined in the protocol

• Measurable disease defined as one or more target lesions according to RECIST

• Life expectancy of at least 3 months

• Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1

• Other protocol defined inclusion criteria could apply

Exclusion Criteria:

• Pretreatment with regorafenib.

• Subjects who in the opinion of the subject and investigator would benefit more from regorafenib treatment (except where regorafenib is not reimbursed in the country)

• Skin rash Common Terminology Criteria for AEs (CTCAE) Grade greater than 1 from previous anti-EGFR therapy at time of randomization

• Magnesium less than 0.9 milligram per deciliter (mg/dL)

• Known hypersensitivity to any of the treatment ingredients. Known previous Grade 3-4 infusion related reactions with anti-EGFR mABs

• Other protocol defined exclusion criteria could apply