{"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":"DB-1305-O-1001","nct_id":"NCT05438329","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=db-1305-o-1001-nct05438329. 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":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 DB-1305/BNT325 at Dose Level 1","label":"DB-1305/BNT325 Dose Level 1","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 2","label":"DB-1305/BNT325 Dose Level 2","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 3","label":"DB-1305/BNT325 Dose Level 3","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 4","label":"DB-1305/BNT325 Dose Level 4","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 5","label":"DB-1305/BNT325 Dose Level 5","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 6","label":"DB-1305/BNT325 Dose Level 6","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 7","label":"DB-1305/BNT325 Dose Level 7","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 in combination with pembrolizumab","label":"DB-1305/BNT325 in combination with pembrolizumab","type":"EXPERIMENTAL"},{"description":"subjects with Non-Small Cell Lung Cancer (NSCLC) with actionable genetic alterations (AGAs) who will receive DB-1305/BNT325 on either dose level 1 or dose level 2","label":"DB-1305/BNT325 Dose Expansion 1","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on either dose level 1 or dose level 2","label":"DB-1305/BNT325 Dose Expansion 2","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with OC who will receive DB-1305/BNT325 on either dose level 1 or dose level 2","label":"DB-1305/BNT325 Dose Expansion 3","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with BC who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 4","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with Triple-Negative Breast Cancer (TNBC) who have progressed on or after standard systemic treatments and without prior treatment of sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 5","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with TNBC with treatment failure on sacituzumab govitecan who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 6","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with EC who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 7","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with malignant mesothelioma will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 8","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with Cervical Cancer (CC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 9","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with pancreatic cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"Experimental: DB-1305/BNT325 Dose Expansion 10","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with Castration-Resistant Prostate Cancer (CRPC) who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 11","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with pembrolizumab","label":"DB-1305/BNT325 Dose Expansion PB1","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 8","label":"Experimental: DB-1305/BNT325 Dose Level 8","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 in combination with BNT327","label":"Experimental: DB-1305/BNT325 in combination with BNT327","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with NSCLC without AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327","label":"Experimental: DB-1305/BNT325 Dose Expansion PM1","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with NSCLC with AGAs who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327","label":"Experimental: DB-1305/BNT325 Dose Expansion PM2","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with CC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327","label":"Experimental: DB-1305/BNT325 Dose Expansion PM3","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with OC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327","label":"Experimental: DB-1305/BNT325 Dose Expansion PM4","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with TNBC who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327","label":"Experimental: DB-1305/BNT325 Dose Expansion PM5","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with head and neck cancer who will receive DB-1305/BNT325 on a selected dose level (RP2D)","label":"DB-1305/BNT325 Dose Expansion 12","type":"EXPERIMENTAL"},{"description":"Enrolled subjects will receive DB-1305/BNT325 at Dose Level 9","label":"DB-1305/BNT325 Dose Level 9","type":"EXPERIMENTAL"},{"description":"Enrolled subjects with NSCLC without AGA who will receive DB-1305/BNT325 on a selected dose level in combination with BNT327","label":"DB-1305/BNT325 Dose Expansion 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National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.","timeFrame":"up to 28 days after Cycle 1 Day 1"},{"measure":"Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.","timeFrame":"Up to 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first."},{"measure":"Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.","timeFrame":"Up 30 days after last study treatment administration or before starting new anticancer treatment, whichever comes first."},{"measure":"Maximum Tolerated Dose (MTD) of DB-1305/BNT325","timeFrame":"At the end of Cycle 1 (each cycle is up to 21 days)"},{"measure":"Phase 1: RP2D of DB-1305/BNT325","timeFrame":"From first study treatment administration until the initiation of Phase 2a, approximately up to 12 months."},{"measure":"Phase 2a: Percentage of Participants with 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It can be ordered.","url":"https://www.erudio.com/trials/db-1305-o-1001-nct05438329"}