{"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":null,"indication":null,"name":"NCT03449381","nct_id":"NCT03449381","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03449381. 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":null,"label":"Dose Escalation","type":"EXPERIMENTAL"},{"description":null,"label":"Dose Expansion","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-11-13","type":"ACTUAL"},"conditions":["Neoplasms"],"enrollment":{"count":266,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"BI 907828","otherNames":["brigimadlin"],"type":"DRUG"}],"last_update":"2026-03-31","lead_sponsor":"Boehringer Ingelheim","official_title":"A Phase Ia/Ib, Open Label, Multicenter, Dose-escalation Study of BI 907828 (Brigimadlin) in Patients With Advanced or Metastatic Solid Tumors","overall_status":"COMPLETED","phases":["PHASE1"],"primary_completion_date":{"date":"2025-11-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Phase Ia- Maximum tolerated dose (MTD) based on number of patients with dose limiting toxicities (DLTs) during first treatment cycle","timeFrame":"Up to 28 days"},{"measure":"Phase Ib - Progression-free survival","timeFrame":"Up to 24 months"},{"measure":"Phase Ia - Number of patients with DLTs during first treatment cycle (21 days, Arm A; 28 days, Arm B)","timeFrame":"Up to 28 days"},{"measure":"Phase Ib - Number of patients with DLTs during the first treatment cycle","timeFrame":"Up to 28 days"}],"references":[{"citation":"Gollner A, Rudolph D, Weyer-Czernilofsky U, Baumgartinger R, Jung P, Weinstabl H, Ramharter J, Grempler R, Quant J, Rinnenthal J, Perez Pitarch A, Golubovic B, Gerlach D, Bader G, Wetzel K, Otto S, Mandl C, Boehmelt G, McConnell DB, Kraut N, Sini P. Discovery and Characterization of Brigimadlin, a Novel and Highly Potent MDM2-p53 Antagonist Suitable for Intermittent Dose Schedules. Mol Cancer Ther. 2024 Dec 3;23(12):1689-1702. doi: 10.1158/1535-7163.MCT-23-0783.","pmid":"39259562","type":"DERIVED"},{"citation":"LoRusso P, Yamamoto N, Patel MR, Laurie SA, Bauer TM, Geng J, Davenport T, Teufel M, Li J, Lahmar M, Gounder MM. The MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced or Metastatic Solid Tumors: Results of a Phase Ia, First-in-Human, Dose-Escalation Study. Cancer Discov. 2023 Aug 4;13(8):1802-1813. doi: 10.1158/2159-8290.CD-23-0153.","pmid":"37269344","type":"DERIVED"}],"start_date":{"date":"2018-06-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"This Study Aims to Find the Best Dose of BI 907828 (Brigimadlin) in Patients With Different Types of Advanced Cancer (Solid Tumors)","url":"https://clinicaltrials.gov/study/NCT03449381"},"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/nct03449381"}