Sym004 vs Standard of Care in Subjects With Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Sym004 (12 mg/kg); Sym004 (9/6 mg/kg); Best Supportive Care (BSC); Fluorouracil (5-FU); Capecitabine
Intervention description: Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.; Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.; 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.; 5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.; Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.
Intervention MeSH terms: Capecitabine; Fluorouracil; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 254.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Colorectal Cancer; Best Supportive Care; Capecitabine; Fluorouracil (5-FU); Sym004

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).
    

Eligibility 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