Drugs / DB-1305
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06953089 | Jul 2025 → Jun 2030 expected | cancer | DualityBio Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-05-20 | DualityBio Inc. | Results 2026 ESMO Breast Cancer | Presentation of Preliminary Clinical Data for DualityBio and BioNTech’s Next-Generation TROP2 ADC Sacituzumab Drozuntecan in First-Line Advanced TNBC dualitybiologics.com ↗
The data were presented in a Rapid Oral presentation at the 2026 European Society for Medical Oncology Breast Cancer (“ESMO Breast Cancer”) Annual Meeting in Berlin, Germany. |
| 2025-04-29 | DualityBio Inc. | Results DualityBio Presented Early Clinical and Preclinical Data for Novel ADC Therapy Candidates at AACR 2025 dualitybiologics.com ↗
In this cohort, the combination of BNT325/DB-1305 plus BNT327 showed early signs of anti-tumor activity in efficacy evaluable patients (n=13), with 7 patients achieving partial response (PR) and 3 with stable disease (SD). |
| 2024-01-31 | BioNTech SE | Regulatory BioNTech and DualityBio Receive FDA Fast Track Designation for Next-Generation Antibody-Drug Conjugate Candidate BNT325/DB-1305 biontech.com ↗ |
| 2023-10-16 | BioNTech SE | Results BioNTech to Present Multiple Program Updates Across Modalities at ESMO Congress 2023 biontech.com ↗
First-in-human data from Phase 1/2 study with next-generation Trop-2 targeting ADC candidate BNT325 (DB-1305) in advanced/metastatic solid tumors show encouraging initial efficacy signals and a manageable safety profile |
All press releases naming this drug 4 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DB-1305 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06953089 ↗ |
| Known as | BNT325 | “DB-1305/BNT325” NCT06953089 ↗ |
| Route | Intravenous | “Administered I.V.” NCT06953089 ↗ |