{"preliminary_commentary":{"by_channel":{"x_thread":12,"youtube":7,"podcast":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05379595\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"OrigAMI-1","nct_id":"NCT05379595","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=origami-1-nct05379595. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"OrigAMI-1","arms":[{"description":"Participants with left-sided colorectal cancer (CRC) in Cohort A (no prior anti-epidermal growth factor receptor \\[EGFR\\] therapy) and in Cohort B (post anti-EGFR therapy), and right-sided CRC in Cohort C (with or without anti-EGFR therapy), will be administered intravenous (IV) infusion of amivantamab 1050 milligrams (mg) if body weight (BW) is less than (\\<) 80 kilograms (kg) or 1400 mg if BW is greater than or equal to (\\>=) 80 kg, as monotherapy on Days 1 and 15 of Cycle 2 (28-days cycle).","label":"Cohorts A, B, and C: Amivantamab Monotherapy","type":"EXPERIMENTAL"},{"description":"Participants who are anti-EGFR treatment naïve, have not received oxaliplatin-based chemotherapy in the metastatic setting, will be administered IV infusion of amivantamab 1050 or 700 mg (dose level 0 \\[DL0\\]) if BW is \\<80 kg, or 1400 or 1050 mg (dose de-escalation \\[DL-1\\]) if BW is \\>= 80 kg, on Days -1, -2, 8 and 22 of Cycle 1 and along with mFOLFOX6 SOC chemotherapy on Days 1 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 (each cycle of 28 days) in Phase 1b dose confirmation Cohort (Cohort Ph1b-D). Participant in Phase 2 Cohort (Cohort D) will receive recommended Phase 2 combination dose (RP2CD) of amivantamab along with mFOLFOX6 SOC chemotherapy determined in Cohort Ph1b-D.","label":"Cohorts Ph1b-D and D: Amivantamab+5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6)","type":"ACTIVE_COMPARATOR"},{"description":"Participants who are anti-EGFR treatment naïve, have not received irinotecan-based chemotherapy in the metastatic setting, will be administered IV infusion of Amivantamab along with FOLFIRI SOC chemotherapy on Days -1, -2, and 8 of Cycle 1 and Days 1 and 15 of Cycle 2 in Ph1b-E. For Cohort E, RP2CD determined in Ph1b-E will be administered.","label":"Cohorts Ph1b-E and E: Amivantamab+5-Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI)","type":"ACTIVE_COMPARATOR"},{"description":"Participant who are treatment-naïve for right-sided unresectable or metastatic CRC. Participants will receive Amivantamab along with mFOLFOX6 SoC chemotherapy.","label":"Cohort F: Amivantamab + mFOLFOX6","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2031-05-11","type":"ESTIMATED"},"conditions":["Advanced or Metastatic Colorectal Cancer"],"enrollment":{"count":225,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Amivantamab IV","otherNames":["RYBREVANT","JNJ-61186372"],"type":"BIOLOGICAL"},{"name":"Fluorouracil","otherNames":[],"type":"BIOLOGICAL"},{"name":"Leucovorin","otherNames":[],"type":"BIOLOGICAL"},{"name":"Oxaliplatin","otherNames":[],"type":"BIOLOGICAL"},{"name":"Irinotecan","otherNames":[],"type":"BIOLOGICAL"},{"name":"Amivantamab","otherNames":["JNJ-61186372","RYBREVANT"],"type":"BIOLOGICAL"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Research & Development, LLC","official_title":"A Phase 1b/2, Open-Label Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-04-27","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Cohorts A, B, and C: Objective Response Rate (ORR)","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts Ph1b-D and Ph1b-E: Number of Participants with Dose-limiting Toxicity (DLT)","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts Ph1b-D and Ph1b-E: Number of Participants with DLT by Severity","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts D and E: Number of Participants with Adverse Events (AE)","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts D and E: Number of Participants with Laboratory Values Abnormalities","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts D and E: Number of Participants with Vital Signs Abnormalities","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts F: Number of Participants with Adverse Events (AE)","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts F: Number of Participants with Laboratory Values Abnormalities","timeFrame":"Up to 4 years 3 months"},{"measure":"Cohorts F: Number of Participants with Vital Signs Abnormalities","timeFrame":"Up to 4 years 3 months"}],"references":[{"citation":"Oberstein PE, Hecht JR, Raghav K, Pietrantonio F, Arnold D, Moreno V, Van Cutsem E, Malik RA, Hong YS, Lee MA, Yu-Li Su H, Lee J, Chandana S, Cruz-Correa M, Yuan Y, Ahmad A, Lai KM, Hsu HC, Chen EX, Elez E, Lin CC, Lopez C, Prenen H, Rosello-Keranen S, Velez H, Yeh YM, Heinemann V, Eng C, Beom SH, Tejpar S, Chowdhury S, Lyu X, Kamat M, Curtin JC, Patel B, Xie J, Bhattacharya R, Schnepp RW, Yilmaz E, Iwasawa R, Daksh M, Lorenzini P, Thayu M, Baig M, Kim HS, Han SW. Amivantamab Monotherapy in Chemorefractory RAS/BRAF Wild-Type Metastatic Colorectal Cancer: Results From OrigAMI-1, an Open-Label, Phase Ib/II Study. J Clin Oncol. 2026 Jun 10;44(17):1624-1634. doi: 10.1200/JCO-25-02187. Epub 2026 Apr 21.","pmid":"42013403","type":"DERIVED"}],"start_date":{"date":"2022-07-29","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer","url":"https://clinicaltrials.gov/study/NCT05379595"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/origami-1-nct05379595"}