Drugs / DB-1310
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06220864 | Feb 2024 → Dec 2027 expected | neoplasm | Synnovation Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05785741 | Aug 2023 → Dec 2027 expected | neoplasm | DualityBio Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | DualityBio Inc. | Regulatory DualityBio’s DB-1310 Granted U.S. FDA Fast Track Designation for HR+/HER2- Breast Cancer dualitybiologics.com ↗
Duality Biotherapeutics (“DualityBio”, HKEX:09606) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310. |
| 2025-07-22 | DualityBio Inc. | Regulatory DualityBio's Next-Generation HER3 ADC DB-1310 Granted FDA Fast Track Designation dualitybiologics.com ↗
DualityBio (HKEX Stock Code: 9606.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to its next-generation HER3-targeting antibody-drug conjugate (ADC) DB-1310. |
All press releases naming this drug 4 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DB-1310 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06220864 ↗ |
| Route | Intravenous | “Administered I.V.” NCT05785741 ↗ |