Therapy Detail
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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|BNT-323|BNT 323|BNT323|Trastuzumab pamirtecan | HER2 (ERBB2) Antibody 78 HER2 (ERBB2) Antibody-Drug Conjugate 33 | 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 |
| NCT06827236 | Phase Ib/II | DB-1303 BNT327 + DB-1303 BNT327 | A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer | Recruiting | USA | 1 |
| 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 | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BEL | AUS | ARG | 3 |
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