{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"400"},{"groupId":"OG001","value":"400"}]}],"title":"Cetuximab loading dose"},{"categories":[{"measurements":[{"groupId":"OG000","value":"250"},{"groupId":"OG001","value":"250"}]}],"title":"Cetuximab maintenance dose"},{"categories":[{"measurements":[{"comment":"Irinotecan was not administered during Part 1","groupId":"OG000","value":"NA"},{"groupId":"OG001","value":"180"}]}],"title":"Irinotecan"}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"10"}],"units":"Participants"}],"description":"Using a 3+3 dose escalation model, the maximum tolerated dose of each combination was determined by assessing dose-limiting toxicities in each cohort. RP2D = one dose lever lower than the MTD\n\nPart 1:\n\nCohort 1: MM-121: 12 mg/kg MM-121 QW + Cetuximab: 400 mg/m2 loading dose/200 mg/m2 (400/200) QW maintenance Cohort 2a: MM-121: 20 mg/kg IV QW + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 2b: MM-121: 12 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 3a: MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW (40/20) + Cetuximab: 400 / 200 mg/m2 maintenance IV QW Cohort 3b: MM-121 20 mg/kg IV QW + Cetuximab: 400 /250 mg/m2 maintenance IV QW Cohort 4: MM-121: 40/20 mg/kg IV QW + Cetuximab: 400 / 250 mg/m2 maintenance IV QW\n\nPart 2:\n\nCohort 1: MM-121: 20 mg/kg IV QW + Cetuximab: 400/200 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2 IV Q2W Cohort 2: MM-121: 40 / 20 mg/kg IV QW + Cetuximab: 400/250 mg/m2 maintenance IV QW + Irinotecan: 180 mg/m2","groups":[{"description":"increasing doses of weekly MM-121 + weekly cetuximab\n\nMM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)\n\nCetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)","id":"OG000","title":"Part 1: MM-121 + Cetuximab"},{"description":"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1\n\nMM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)\n\nIrinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)\n\nCetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)","id":"OG001","title":"Part 2: MM-121 + Cetuximab + Irinotecan"}],"paramType":"NUMBER","populationDescription":"Number of patients participating in dose-escalation portion (excluding expansion cohort patients who were not evaluated for DLTs and thus not included in determining MTD/RP2D) NOTE: MTD of MM-121 provided in separate endpoint entry","reportingStatus":"POSTED","timeFrame":"From date of first dose to 30 days after termination, the longest 48.1 weeks","title":"To Further Determine the Safety Parameters of the MM-121 + Cetuximab and MM-121 + Cetuximab + Irinotecan Combination by Determining the Recommended Phase 2 Dose (RP2D) of the Combination(s): Cetuximab and Irinotecan","type":"PRIMARY","unitOfMeasure":"mg/m2"}