{"entity":{"id":"nct05438329","kind":"trial","name":"First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors","aka":[],"tldr":"A phase 1/2 trial of Pembrolizumab and PM8002 in advanced solid tumours, run by DualityBio Inc., active and no longer recruiting.","summary":"First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors. ClinicalTrials.gov record last updated 2026-05-12: active not recruiting. Enrollment is planned at 1123 participants. Primary completion is estimated at 2027-08-13. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications. Registered interventions: DB-1305/BNT325, Pembrolizumab, BNT327. Registered primary measures: Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.; Phase 1: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.; Phase 1: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0..","status":"active","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT05438329","url":"https://clinicaltrials.gov/study/NCT05438329"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":[],"targets":["trop2"],"drugs":["pembrolizumab","pm8002"],"companies":["dualitybio","biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["ClinicalTrials.gov record last updated 2026-05-12: active not recruiting. Enrollment is planned at 1123 participants. Primary completion is estimated at 2027-08-13. No tabular results are posted on ClinicalTrials.gov; this does not exclude separate publications."],"nct":"NCT05438329","phase":"1/2","setting":"First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors","sponsor":"DualityBio Inc.","participation":[{"nct":"NCT05438329","source":"https://clinicaltrials.gov/study/NCT05438329","fetchedAt":"2026-10-07T16:53:42.604Z","studySha256":"bf6f42879aac9dc5179a5b21b829922e4d4f4f0809578f881a32ddc4c8d016cc","overallStatus":"ACTIVE_NOT_RECRUITING","lastUpdatePosted":"2026-05-12","leadSponsor":"DualityBio Inc.","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1123,"enrolmentType":"ESTIMATED","siteCount":93,"recruitingSiteCount":0,"countries":["China","Puerto Rico","United States"]}],"started":"2022-07-19","startedType":"actual","enrolled":1123,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05438329/","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":"db-1305","kind":"drug","name":"DB-1305 / BNT325","route":"/drugs/db-1305/"},{"id":"pembrolizumab","kind":"drug","name":"Pembrolizumab","route":"/drugs/pembrolizumab/"},{"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/"}]}}