{"commentary":{"count":3,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":3},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":false},"name":"NCT05382559","nct_id":"NCT05382559","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05382559. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":750,"size":"focused","size_rule":"Focused: 1–12 commentary sources"},"registry":{"acronym":null,"arms":[{"description":"Participants will receive ASP3082 in a 21-day cycle.","label":"ASP3082 Dose Escalation (Monotherapy Part 1)","type":"EXPERIMENTAL"},{"description":"Participants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.","label":"ASP3082 Dose Expansion (Monotherapy Part 2)","type":"EXPERIMENTAL"},{"description":"Participants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.","label":"ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)","type":"EXPERIMENTAL"},{"description":"Participants will receive ASP3082 or ASP3082 + Cetuximab with dose level(s) selected from dose escalation (part 1) in a 21-day cycle. Cetuximab will be administered weekly.","label":"ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)","type":"EXPERIMENTAL"},{"description":"Participants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.","label":"ASP3082 China Safety Cohort","type":"EXPERIMENTAL"},{"description":"Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with FOLFIRINOX (leucovorin \\[LV\\]/fluorouracil \\[5-FU\\]/irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.","label":"Treatment naive PDAC cohort ASP3082 + FOLFIRINOX","type":"EXPERIMENTAL"},{"description":"Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with Nab-P + GEM (nanoparticle albumin-bound-paclitaxel plus gemcitabine) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.","label":"Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + Gemcitabine","type":"EXPERIMENTAL"},{"description":"Participants with KRAS G12D mutant will receive ASP3082 in combination with docetaxel in a 21-day cycle.","label":"ASP3082 + Docetaxel - NSCLC","type":"EXPERIMENTAL"},{"description":"Participants with KRAS G12D mutant will receive ASP3082 in combination with pembrolizumab in a 21-day cycle.","label":"ASP3082 + Pembrolizumab - NSCLC","type":"EXPERIMENTAL"},{"description":"Participants with KRAS G12D mutant will receive ASP3082 in combination with platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed, with or without pembrolizumab in a 21-day cycle.","label":"ASP3082 + (Cisplatin or Carboplatin) and Pemetrexed +/- Pembrolizumab - NSCLC","type":"EXPERIMENTAL"},{"description":"Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with NALIRIFOX (leucovorin\\[LV\\]/fluorouracil\\[5-FU\\]/liposomal irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.","label":"Treatment naive PDAC cohort ASP3082 + NALIRIFOX","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2028-12-31","type":"ESTIMATED"},"conditions":["Solid Tumor"],"enrollment":{"count":681,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Setidegrasib","type":"DRUG"},{"name":"Cetuximab","type":"DRUG"},{"name":"Leucovorin","type":"DRUG"},{"name":"Oxaliplatin","type":"DRUG"},{"name":"Fluorouracil","type":"DRUG"},{"name":"Irinotecan","type":"DRUG"},{"name":"Nanoparticle albumin-bound-paclitaxel","type":"DRUG"},{"name":"Gemcitabine","type":"DRUG"},{"name":"Docetaxel","type":"DRUG"},{"name":"Pembrolizumab","type":"DRUG"},{"name":"Cisplatin","type":"DRUG"},{"name":"Carboplatin","type":"DRUG"},{"name":"Pemetrexed","type":"DRUG"},{"name":"Liposomal Irinotecan","type":"DRUG"}],"last_update":"2026-09-30","lead_sponsor":"Astellas Pharma Inc","official_title":"A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation","overall_status":"RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2028-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Incidence of Dose Limiting Toxicities (DLTs)","timeFrame":"Up to 28 Days"},{"measure":"Number of Participants with Adverse Events (AEs)","timeFrame":"Up to 48 months"},{"measure":"Number of Participants with Serious Adverse Events (SAEs)","timeFrame":"Up to 48 months"},{"measure":"Number of Participants with laboratory value abnormalities and/or adverse events (AEs)","timeFrame":"Up to 48 months"},{"measure":"Number of Participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)","timeFrame":"Up to 48 months"},{"measure":"Number of Participants with vital sign abnormalities and/or adverse events (AEs)","timeFrame":"Up to 48 months"},{"measure":"Number of Participants with physical exam abnormalities and/or adverse events","timeFrame":"Up to 48 months"},{"measure":"Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status","timeFrame":"Up to 48 months"}],"references":[{"citation":"Park W, Kasi A, Spira AI, Paz-Ares Rodriguez L, Herzberg BO, Pelster MS, Tolcher AW, Kuboki Y, Kitano S, Shoji H, Wang JS, Berlin JD, Hollebecque A, LoRusso P, Fountzilas C, Cassier PA, Nishina T, Sakai D, Inagaki C, Morgensztern D, Ueno M, Jung M, Kim SW, Janne PA, Italiano A, You B, Macarulla T, Fujii H, Shetty A, Lu Y, Cui D, Kadam S, Gill SC, Toyoshima J, Saito T, Goldman JW. Setidegrasib in Advanced Non-Small-Cell Lung Cancer and Pancreatic Cancer. N Engl J Med. 2026 Apr 9;394(14):1409-1420. doi: 10.1056/NEJMoa2600752. Epub 2026 Mar 25.","pmid":"41879829","type":"DERIVED"}],"start_date":{"date":"2022-06-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of ASP3082 in Adults With Advanced Solid Tumors","url":"https://clinicaltrials.gov/study/NCT05382559"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct05382559"}