{"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":[["nanrilkefusp alfa (SOT101)"],["nanrilkefusp alfa (SOT101)","pembrolizumab"]],"indication":"advanced/metastatic solid tumors","name":"AURELIO-03","nct_id":"NCT04234113","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=aurelio-03-nct04234113. 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":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","label":"Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.25 μg/kg","type":"EXPERIMENTAL"},{"description":"Nanrilkefusp alfa was administered on day 1 (±1 day), day 2, day 8, and day 9 of the 21-day treatment cycle as a once-daily dose.","label":"Part A (nanrilkefusp alfa monotherapy), nanrilkefusp alfa 0.75 μg/kg","type":"EXPERIMENTAL"},{"description":"Nanrilkefusp alfa was 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Cancer","Bladder Cancer","Melanoma","Merkel Cell Carcinoma","Skin Squamous Cell Carcinoma","Microsatellite Instability High","Triple Negative Breast Cancer","Mesothelioma","Thymic Cancer","Cervical Cancer","Biliary Tract Cancer","Hepatocellular Carcinoma","Ovarian Cancer","Gastric Cancer","Head and Neck Squamous Cell Carcinoma","Anal Cancer"],"enrollment":{"count":115,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Nanrilkefusp alfa","otherNames":["SOT101","SO-C101","RLI-15"],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":["KEYTRUDA®"],"type":"DRUG"}],"last_update":"2026-03-27","lead_sponsor":"SOTIO Biotech AG","official_title":"A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors","overall_status":"TERMINATED","phases":["PHASE1"],"primary_completion_date":{"date":"2024-08-31","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants With Dose-limiting Toxicities (DLTs)","timeFrame":"Through Cycle 1 (21 days)"},{"measure":"Number of Participants With Adverse Events (AEs)","timeFrame":"Day 1 up to approximately 2 years and 2.5 months"},{"measure":"Number of Participants With Serious AEs (SAEs)","timeFrame":"Day 1 up to approximately 2 years and 2.5 months"},{"measure":"Number of Participants With AEs Leading to Premature Discontinuation of Nanrilkefusp Alfa","timeFrame":"Day 1 up to approximately 2 years and 2.5 months"},{"measure":"Number of Participants Who Died","timeFrame":"Day 1 up to approximately 2 years and 2.5 months"},{"measure":"Number of Participants With Nanrilkefusp Alfa-related Clinical Laboratory Test Abnormalities (Coagulation; Hematology; Clinical Chemistry; Urinalysis; Thyroid and Cardiac Function)","timeFrame":"Day 1 up to approximately 2 years and 2.5 months"}],"references":[],"start_date":{"date":"2019-06-13","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors","url":"https://clinicaltrials.gov/study/NCT04234113"},"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/aurelio-03-nct04234113"}