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DB-1303 + itraconazole
- Development stage
- Unknown
- Lead developer
- Duality Biotherapeutics
- Modality
- Small Molecules, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
- Administration
- Intravenous, Oral
01
Overview
DB-1303 + itraconazole is a drug combination used in clinical trials to evaluate the drug-drug interaction (DDI) potential of DB-1303 (also known as BNT323). DB-1303 is a next-generation antibody-drug conjugate (ADC) targeting Human Epidermal Growth Factor Receptor 2 (HER2), developed by DualityBio in partnership with BioNTech. It consists of a humanized anti-HER2 monoclonal antibody conjugated to a topoisomerase I inhibitor payload via a cleavable linker. Itraconazole is a potent CYP3A4 inhibitor administered alongside DB-1303 to assess how the inhibition of this metabolic enzyme affects the pharmacokinetics and safety of the ADC's payload. This combination is part of a Phase 1/2a study in patients with HER2-expressing or HER2-mutant advanced solid tumors, including breast, gastric, and endometrial cancers.
- Other names
- BNT323 + itraconazole
02
Targets
TOP1 (DNA Topoisomerase I)CYP3A4 (Cytochrome P450 3A4)ERBB2 (Erb-b2 receptor tyrosine kinase 2)
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