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DB-1303/BNT323
DB-1303/BNT323 is a bispecific antibody that simultaneously engages two distinct immune checkpoints to enhance anti-tumor T-cell responses.
DB-1303/BNT323 is a bispecific antibody that simultaneously engages two distinct immune checkpoints to enhance anti-tumor T-cell responses. Used for Advanced or metastatic solid tumors (Phase 3 development).
At a glance
| Generic name | DB-1303/BNT323 |
|---|---|
| Sponsor | DualityBio Inc. |
| Drug class | Bispecific antibody |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
This bispecific antibody is designed to bind two different immune regulatory targets, thereby overcoming single-checkpoint inhibition limitations and potentially generating more robust anti-tumor immunity. By engaging multiple pathways simultaneously, the drug aims to improve efficacy in checkpoint-resistant tumors and expand the patient population that can benefit from immunotherapy.
Approved indications
- Advanced or metastatic solid tumors (Phase 3 development)
Common side effects
Key clinical trials
- A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) (PHASE3)
- A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (PHASE3)
- A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors (PHASE1, PHASE2)
- A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |