{"entity":{"id":"nct06953089","kind":"trial","name":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 2 trial of BNT324 and PM8002 in advanced solid tumours, run by DualityBio Inc., now recruiting.","summary":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors. ClinicalTrials.gov record last updated 2026-05-22: recruiting. Enrollment is planned at 450 participants. Primary completion is estimated at 2030-06-30. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: DB-1311/BNT324, BNT327, DB-1305/BNT325. Registered primary measures: Part 1: Number of participants with Dose Limiting Toxicities (DLTs).; Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs); Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level].","status":"recruiting","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT06953089","url":"https://clinicaltrials.gov/study/NCT06953089"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["trop2"],"drugs":["bnt324","pm8002"],"companies":["dualitybio","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-05-22: recruiting. Enrollment is planned at 450 participants. Primary completion is estimated at 2030-06-30. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications."],"nct":"NCT06953089","phase":"2","setting":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","participation":[{"nct":"NCT06953089","source":"https://clinicaltrials.gov/study/NCT06953089","fetchedAt":"2026-10-07T16:55:19.231Z","studySha256":"0e3fa2d463c0f7a283883c5879ff0a84d335fd33ce8bd4aff1b25648cb59b7ef","overallStatus":"RECRUITING","lastUpdatePosted":"2026-05-22","leadSponsor":"DualityBio Inc.","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":450,"enrolmentType":"ESTIMATED","siteCount":37,"recruitingSiteCount":37,"countries":["Australia","China","Taiwan","United States"]}],"started":"2025-07-18","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06953089/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"target":[{"id":"trop2","kind":"target","name":"TROP2","route":"/targets/trop2/"}],"drug":[{"id":"bnt324","kind":"drug","name":"BNT324","route":"/drugs/bnt324/"},{"id":"db-1305","kind":"drug","name":"DB-1305 / BNT325","route":"/drugs/db-1305/"},{"id":"pm8002","kind":"drug","name":"PM8002","route":"/drugs/pm8002/"}],"company":[{"id":"biontech","kind":"company","name":"BioNTech","route":"/companies/biontech/"},{"id":"dualitybio","kind":"company","name":"Duality Biotherapeutics","route":"/companies/dualitybio/"}]}}