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DB-1310 + capecitabine
- Development stage
- Phase 2
- Lead developer
- Duality Biotherapeutics
- Modality
- Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Small Molecules
- Administration
- Intravenous, Oral
01
Overview
DB-1310 + capecitabine is an investigational combination regimen pairing DB-1310, a next-generation antibody-drug conjugate (ADC) targeting human epidermal growth factor receptor 3 (HER3/ErbB3), with capecitabine, an oral fluoropyrimidine chemotherapy. Developed by DualityBio, DB-1310 consists of a humanized anti-HER3 IgG1 monoclonal antibody conjugated via a cleavable peptide linker to a proprietary DNA topoisomerase I inhibitor payload (P1021). Capecitabine is a prodrug that is enzymatically converted to 5-fluorouracil (5-FU) in tumor tissues, where it inhibits thymidylate synthase and interferes with DNA synthesis. The combination is being evaluated in a Phase 1/2a clinical trial (NCT05785741) for patients with advanced or metastatic solid tumors, specifically in a dose-expansion cohort for chemotherapy-naïve hormone receptor-positive (HR+), HER2-negative breast cancer.
- Other names
- DB-1310 + XelodaDB-1310 and capecitabineDB1310 and capecitabineDB 1310 and capecitabineXeloda + DB-1310capecitabine + DB-1310
02
Targets
ERBB3 (Erb-b2 receptor tyrosine kinase 3)TS (Thymidylate synthase)
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