Drugs / DB-1317
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07141706 | Sep 2025 → Jun 2028 expected | — | DualityBio Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-08-25 | DualityBio Inc. | Regulatory DualityBio’s ADAM9 ADC DB-1317 Granted FDA Fast Track Designation for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma dualitybiologics.com ↗
DB-1317, a Company-developed antibody-drug conjugate (“ADC”) targeting ADAM9, has been granted Fast Track Designation ("FTD") by the U.S. Food and Drug Administration ("FDA") for the treatment of advanced/unresectable or metastatic pancreatic ductal adenocarcinoma ("PDAC"). |
| 2025-09-24 | DualityBio Inc. | Regulatory DualityBio’s ADAM9-Targeting ADC DB-1317 Receives FDA IND Clearance, Global Clinical Trials Initiated Simultaneously dualitybiologics.com ↗
Furthermore, the U.S. Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) clearance for DB-1317. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-25 | DualityBio Inc. | DualityBio’s ADAM9 ADC DB-1317 Granted FDA Fast Track Designation for the Treatment of Advanced Pancreatic Ductal Adenocarcinoma dualitybiologics.com ↗ |
| 2025-09-24 | DualityBio Inc. | DualityBio’s ADAM9-Targeting ADC DB-1317 Receives FDA IND Clearance, Global Clinical Trials Initiated Simultaneously dualitybiologics.com ↗ |
Evidence & citations 2 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-1317 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07141706 ↗ |
| Route | Intravenous | “Administered I.V.” NCT07141706 ↗ |