drugset
Drugs / DB-1311
last change May 2026 re-read 3 minutes ago

DB-1311

also known as BNT324
Developed for
cancer
Investigated by
BioNTech SE · DualityBio Inc.

Trials 2

today NCT06953089 · Ph 2 NCT05914116 · Ph 1/2
2024202520262027202820292030
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT05914116 Aug 2023 → Dec 2027 expected cancer DualityBio Inc. Recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT06953089 Jul 2025 → Jun 2030 expected cancer DualityBio Inc. Recruiting No outcome recorded

Press releases naming this drug 4 releases

DateIssuerRelease
2026-05-22 DualityBio Inc. First Patient Dosed in Global Pivotal Phase 3 Clinical Trial for BioNTech and DualityBio’s B7-H3 ADC DB-1311/BNT324 in Metastatic Castration-Resistant Prostate Cancer dualitybiologics.com ↗
2025-12-10 DualityBio Inc. Preliminary Phase 1/2 Clinical Data for DualityBio and BioNTech B7H3-Targeting ADC Candidate DB-1311/BNT324 in Advanced Gynecological Cancers Presented at ESMO ASIA 2025 dualitybiologics.com ↗
2024-12-06 DualityBio Inc. Duality Biologics and BioNTech Presented Positive Interim Data for Investigational B7-H3 Antibody-Drug Conjugate BNT324/DB-1311 in Advanced Solid Tumors at the ESMO Asia Congress 2024 dualitybiologics.com ↗
2024-06-24 BioNTech SE BioNTech and DualityBio Receive FDA Fast Track Designation for Antibody-Drug Conjugate Candidate BNT324/DB-1311 in Prostate Cancer biontech.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as DB-1311 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06953089 ↗
1

NCT05914116 ↗
Known as BNT324 “A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors” NCT05914116 ↗
1

“DB-1311/BNT324” NCT06953089 ↗
Route Intravenous “Administered I.V.(intravenous infusion)” NCT05914116 ↗