{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["tusamitamab ravtansine"]],"indication":"advanced solid tumors","name":"NCT02187848","nct_id":"NCT02187848","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct02187848. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Dose escalation administered intravenously, once every two weeks","label":"SAR408701 Main Dose Escalation Cohort","type":"EXPERIMENTAL"},{"description":"Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer","label":"SAR408701 Expansion Cohort colorectal cancer (CRC)","type":"EXPERIMENTAL"},{"description":"Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity","label":"SAR408701 Expansion Cohort non-squamous NSCLC","type":"EXPERIMENTAL"},{"description":"Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma","label":"SAR408701 Expansion Cohort gastric adenocarcinoma","type":"EXPERIMENTAL"},{"description":"Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks","label":"SAR408701 Loading Dose Escalation cohorts (Escalation bis)","type":"EXPERIMENTAL"},{"description":"Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity","label":"SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis)","type":"EXPERIMENTAL"},{"description":"Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks","label":"SAR408701 Expansion Cohort colorectal cancer (CRC-L)","type":"EXPERIMENTAL"},{"description":"Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC","label":"SAR408701 Expansion Cohort small cell lung cancer (SCLC)","type":"EXPERIMENTAL"},{"description":"Dose escalation administered intravenously, once every three weeks","label":"SAR408701 Dose Escalation every 3 weeks cohort","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2024-11-19","type":"ACTUAL"},"conditions":["Neoplasm Malignant"],"enrollment":{"count":254,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"SAR408701","otherNames":[],"type":"DRUG"}],"last_update":"2025-02-10","lead_sponsor":"Sanofi","official_title":"A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors","overall_status":"TERMINATED","phases":["PHASE1"],"primary_completion_date":{"date":"2020-11-10","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of dose limiting adverse events (every 2 week cycle)","timeFrame":"4 weeks"},{"measure":"Assessment of overall response rate using standard imaging and RECIST 1.1 criteria","timeFrame":"Up to 40 months"},{"measure":"Number of dose limiting adverse events (every 3 week cycle)","timeFrame":"3 weeks"}],"references":[{"citation":"Gazzah A, Bedard PL, Hierro C, Kang YK, Abdul Razak A, Ryu MH, Demers B, Fagniez N, Henry C, Hospitel M, Soria JC, Tabernero J. Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study. Ann Oncol. 2022 Apr;33(4):416-425. doi: 10.1016/j.annonc.2021.12.012. Epub 2022 Jan 10.","pmid":"35026412","type":"RESULT"},{"citation":"Tabernero J, Bedard PL, Bang YJ, Vieito M, Ryu MH, Fagniez N, Chadjaa M, Soufflet C, Masson N, Gazzah A. Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens. Cancer Res Commun. 2023 Aug 28;3(8):1662-1671. doi: 10.1158/2767-9764.CRC-23-0284. eCollection 2023 Aug.","pmid":"37645622","type":"RESULT"},{"citation":"Gazzah A, Ternes N, Lee JS, Wang E, Carene D, Wang H, Masson N, Boitier E, Lartigau A, Mace N, Chadjaa M, Dib C, Nunes M, Muzard G, Longuemaux-Valence S, Bauchet AL. Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. Transl Oncol. 2026 Jan;63:102615. doi: 10.1016/j.tranon.2025.102615. Epub 2025 Dec 3.","pmid":"41337813","type":"DERIVED"}],"start_date":{"date":"2014-07-23","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Evaluation of SAR408701 in Patients With Advanced Solid Tumors","url":"https://clinicaltrials.gov/study/NCT02187848"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct02187848"}