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Therapy Name DB-1303
Synonyms
Therapy Description

DB-1303 is an antibody-drug conjugate (ADC) composed of a biosimilar to the ERBB2 (HER2)-targeted antibody Herceptin (trastuzumab) conjugated to the topoisomerase I inhibitor P1003, which potentially leads to growth inhibition of ERBB2 (HER2)-expressing tumor cells and tumor regression (European Journal of Cancer 174 (2022): S91).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
DB-1303 DB1303|DB 1303 HER2 (ERBB2) Antibody 76 HER2 (ERBB2) Antibody-Drug Conjugate 31 DB-1303 is an antibody-drug conjugate (ADC) composed of a biosimilar to the ERBB2 (HER2)-targeted antibody Herceptin (trastuzumab) conjugated to the topoisomerase I inhibitor P1003, which potentially leads to growth inhibition of ERBB2 (HER2)-expressing tumor cells and tumor regression (European Journal of Cancer 174 (2022): S91).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT05150691 Phase Ib/II DB-1303 A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors Recruiting USA | AUS 2
NCT06018337 Phase III Nab-paclitaxel Paclitaxel DB-1303 Capecitabine A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) Recruiting USA | POL | ITA | HUN | GBR | FRA | CAN | BEL | AUS 3


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