{"preliminary_commentary":{"by_channel":{"x_thread":26,"youtube":19,"podcast":13},"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":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03401385\", \"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."},"commentary_summary":null,"drugs_tested":[["datopotamab deruxtecan"]],"indication":"advanced solid tumors","name":"TROPION-PanTumor01","nct_id":"NCT03401385","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=tropion-pantumor01-nct03401385. 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":null,"arms":[{"description":"All participants enrolled in the dose escalation part","label":"Dose Escalation - All Participants","type":"EXPERIMENTAL"},{"description":"All participants enrolled in the dose expansion part","label":"Dose Expansion - All Participants","type":"EXPERIMENTAL"}],"collaborators":["Daiichi Sankyo","AstraZeneca"],"completion_date":{"date":"2028-01-01","type":"ESTIMATED"},"conditions":["Hormone Receptor Positive Breast Cancer","Triple Negative Breast Cancer","Non-small Cell Lung Cancer"],"enrollment":{"count":890,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Datopotamab Deruxtecan (Dato-DXd)","otherNames":["DS1062a","Study treatment"],"type":"DRUG"},{"name":"Steroid Containing Mouthwash","otherNames":[],"type":"DRUG"},{"name":"Non-Steroid Containing Mouthwash","otherNames":[],"type":"OTHER"}],"last_update":"2026-09-01","lead_sponsor":"Daiichi Sankyo Co., Ltd.","official_title":"Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors (TROPION-PanTumor01)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2028-01-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of participants with dose-limiting toxicities","timeFrame":"Within 8 cycles (each cycle is 21 days)"},{"measure":"Number of participants with adverse events (AEs)","timeFrame":"When all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)"},{"measure":"Number of participants with Grade >/= 2 oral mucositis/stomatitis in Sub-Study","timeFrame":"At 8 weeks"}],"references":[{"citation":"Bardia A, Krop IE, Kogawa T, Juric D, Tolcher AW, Hamilton EP, Mukohara T, Lisberg A, Shimizu T, Spira AI, Tsurutani J, Damodaran S, Papadopoulos KP, Greenberg J, Kobayashi F, Zebger-Gong H, Wong R, Kawasaki Y, Nakamura T, Meric-Bernstam F. Datopotamab Deruxtecan in Advanced or Metastatic HR+/HER2- and Triple-Negative Breast Cancer: Results From the Phase I TROPION-PanTumor01 Study. J Clin Oncol. 2024 Jul 1;42(19):2281-2294. doi: 10.1200/JCO.23.01909. Epub 2024 Apr 23.","pmid":"38652877","type":"DERIVED"},{"citation":"Heist RS, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung SSM, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer Treat Rev. 2024 Apr;125:102720. doi: 10.1016/j.ctrv.2024.102720. Epub 2024 Mar 11.","pmid":"38502995","type":"DERIVED"},{"citation":"Shimizu T, Sands J, Yoh K, Spira A, Garon EB, Kitazono S, Johnson ML, Meric-Bernstam F, Tolcher AW, Yamamoto N, Greenberg J, Kawasaki Y, Zebger-Gong H, Kobayashi F, Phillips P, Lisberg AE, Heist RS. First-in-Human, Phase I Dose-Escalation and Dose-Expansion Study of Trophoblast Cell-Surface Antigen 2-Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Non-Small-Cell Lung Cancer: TROPION-PanTumor01. J Clin Oncol. 2023 Oct 10;41(29):4678-4687. doi: 10.1200/JCO.23.00059. Epub 2023 Jun 16.","pmid":"37327461","type":"DERIVED"}],"start_date":{"date":"2018-01-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)","url":"https://clinicaltrials.gov/study/NCT03401385"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/tropion-pantumor01-nct03401385"}