{"entity":{"id":"bnt324","kind":"drug","name":"BNT324","aka":[],"tldr":"BNT324 is an experimental antibody-drug conjugate from BioNTech SE in phase 3 trials for prostate cancer and non-small-cell lung cancer, aimed at B7-H3.","summary":"BNT324 (DB-1311) is an antibody-drug conjugate developed by BioNTech SE. Its target is B7-H3 (the sponsor names B7-H3). The sponsor states: BNT324 (DB-1311) is an antibody-drug conjugate targeting B7-H3, given as an intravenous infusion in 21-day cycles; a phase 3 trial compares it with docetaxel in metastatic castration-resistant prostate cancer. It is the investigational product in 2 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including the phase 3 study NCT07365995 (A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer), in prostate cancer and non-small-cell lung cancer. The largest, NCT07365995, plans to enrol 736 participants with primary completion expected 2031-02. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of BNT324","url":"https://clinicaltrials.gov/search?intr=DB-1311"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","nsclc"],"sections":[],"technologies":[],"targets":["b7h3"],"drugs":[],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":["nct07365995","nct05914116","nct06892548","nct06953089"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"DB-1311","modality":"ADC","mechanism":"BNT324 (DB-1311) is an antibody-drug conjugate targeting B7-H3, given as an intravenous infusion in 21-day cycles; a phase 3 trial compares it with docetaxel in metastatic castration-resistant prostate cancer.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/bnt324/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"target":[{"id":"b7h3","kind":"target","name":"B7-H3","route":"/targets/b7h3/"}],"company":[{"id":"biontech","kind":"company","name":"BioNTech","route":"/companies/biontech/"}],"trial":[{"id":"nct06892548","kind":"trial","name":"A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer","route":"/trials/nct06892548/"},{"id":"nct05914116","kind":"trial","name":"A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors","route":"/trials/nct05914116/"},{"id":"nct07365995","kind":"trial","name":"A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer","route":"/trials/nct07365995/"},{"id":"nct06953089","kind":"trial","name":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors","route":"/trials/nct06953089/"}]}}