{"preliminary_commentary":{"by_channel":{"x_thread":2,"youtube":1},"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":[["DB-1311"]],"indication":"advanced/metastatic solid tumors","name":"NCT05914116","nct_id":"NCT05914116","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct05914116. 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":"Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 1 on Day 1 of each cycle Q3W (every 3 weeks)","label":"DB-1311/BNT324 Dose Level 1","type":"EXPERIMENTAL"},{"description":"Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 2 on Day 1 of each cycle Q3W","label":"DB-1311/BNT324 Dose Level 2","type":"EXPERIMENTAL"},{"description":"Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 3 on Day 1 of each cycle Q3W","label":"DB-1311/BNT324 Dose Level 3","type":"EXPERIMENTAL"},{"description":"Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 4 on Day 1 of each cycle Q3W","label":"DB-1311/BNT324 Dose Level 4","type":"EXPERIMENTAL"},{"description":"Enrolled Subjects will receive a single-dose of DB-1311/BNT324 at Dose Level 5 on Day 1 of each cycle Q3W","label":"DB-1311/BNT324 Dose Level 5","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic SCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.","label":"DB-1311/BNT324 Dose Expansion 1","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic NSCLC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.","label":"DB-1311/BNT324 Dose Expansion 2","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic ESCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 3","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.","label":"DB-1311/BNT324 Dose Expansion 4","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic melanoma who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 5","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic HCC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 6","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic cervical cancer who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 7","type":"EXPERIMENTAL"},{"description":"Subjects with other advanced or metastatic solid tumors who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 8","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic HNSCC (not including nasopharyngeal carcinoma \\[NPC\\]) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 9","type":"EXPERIMENTAL"},{"description":"Subjects with advanced or metastatic rare tumor types who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 10","type":"EXPERIMENTAL"},{"description":"Subjects with metastatic CRPC who have progressed on or after standard systemic treatments including no more than 2 lines of systemic chemotherapy, novel hormone therapy and lutetium-177 radioligand therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 11","type":"EXPERIMENTAL"},{"description":"Taxane-naive subjects with metastatic CRPC who have progressed on or after novel hormone therapy, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 12","type":"EXPERIMENTAL"},{"description":"Subjects with advanced/unresectable, or metastatic HNSCC (not including NPC) who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324.","label":"DB-1311/BNT324 Dose Expansion 13","type":"EXPERIMENTAL"},{"description":"Subjects with epithelial OC who have had 1-3 prior lines of systemic treatment and are platinum-resistant, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324 randomized at dose level 1 or 2.","label":"DB-1311/BNT324 Dose Expansion 14","type":"EXPERIMENTAL"},{"description":"Subjects with Subjects with advanced/unresectable, or metastatic melanoma, ESCC, PROC and CC who have progressed on or after standard systemic treatments, a 21-day treatment cycle (i.e., once every 3 weeks) via IV will be used for DB-1311/BNT324.\n\nLopinavir and ritonavir/ Itraconazole will be administered orally twice a day/ once a day.","label":"DB-1311/BNT324 Dose Expansion 15","type":"EXPERIMENTAL"},{"description":"Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg QD orally.","label":"DB-1311/BNT324 Dose Expansion 16","type":"EXPERIMENTAL"},{"description":"Taxane-naive subjects with metastatic CRPC who have progressed on or after NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with abiraterone 1000mg QD orally.","label":"DB-1311/BNT324 Dose Expansion 17","type":"EXPERIMENTAL"},{"description":"CSPC subjects with suboptimal PSA response to ADT/NHT, a 21-day treatment cycle (i.e., once every 3 weeks) via intravenous infusion will be used for DB-1311/BNT324, combined with enzalutamide 160mg or abiraterone 1000mg QD orally.","label":"DB-1311/BNT324 Dose Expansion 18","type":"EXPERIMENTAL"}],"collaborators":["BioNTech SE"],"completion_date":{"date":"2028-05","type":"ESTIMATED"},"conditions":["Advanced Solid Tumors"],"enrollment":{"count":862,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"DB-1311","otherNames":[],"type":"DRUG"},{"name":"Lopinavir and Ritonavir Tablets","otherNames":[],"type":"DRUG"},{"name":"itraconazole","otherNames":[],"type":"DRUG"},{"name":"Enzalutamide","otherNames":[],"type":"DRUG"},{"name":"Abiraterone","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-21","lead_sponsor":"DualityBio Inc.","official_title":"A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects With Advanced/Metastatic Solid Tumors","overall_status":"RECRUITING","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2027-12","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs","timeFrame":"up to 21 days after Cycle 1 Day 1"},{"measure":"Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1 & Phase 2a: vital sign measurements","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1& Phase 2a: clinical safety laboratory parameters","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1& Phase 2a: Electrocardiogram (ECG) parameters","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"},{"measure":"Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324","timeFrame":"Up to the completion of Part 1 (assessed up to 12 months)"},{"measure":"Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324","timeFrame":"Up to the completion of Part 1 (assessed up to 12 months)"},{"measure":"Phase 2a: Objective Response Rate (ORR) as determined by investigator","timeFrame":"Up to follow-up period, approximately 1 year post-treatment"}],"references":[],"start_date":{"date":"2023-08-17","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors","url":"https://clinicaltrials.gov/study/NCT05914116"},"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/nct05914116"}