Therapy Detail

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Therapy Name Datopotamab deruxtecan
Synonyms
Therapy Description

Datopotamab deruxtecan (DS-1062a) is an antibody-drug conjugate (ADC) comprising an antibody that targets TROP2 linked to the topoisomerase I inhibitor DXd, which may induce apoptosis and inhibit tumor growth (PMID: 34413126).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Datopotamab deruxtecan Dato-DXd|DS1062a|DS 1062a|DS-1062a TROP2 Antibody 8 Datopotamab deruxtecan (DS-1062a) is an antibody-drug conjugate (ADC) comprising an antibody that targets TROP2 linked to the topoisomerase I inhibitor DXd, which may induce apoptosis and inhibit tumor growth (PMID: 34413126).

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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
NCT06176261 Phase II Datopotamab deruxtecan DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs Recruiting USA 0
NCT04656652 Phase III Docetaxel Datopotamab deruxtecan Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 16
NCT05104866 Phase III Gemcitabine Capecitabine Datopotamab deruxtecan Vinorelbine Eribulin A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL 11
NCT05629585 Phase III Datopotamab deruxtecan Capecitabine + Pembrolizumab Datopotamab deruxtecan + Durvalumab A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 9
NCT06279728 Expanded access Datopotamab deruxtecan Medical Access Program for Datopotamab Deruxtecan in NSCLC Patients Available USA 0
NCT05866432 Phase II Datopotamab deruxtecan Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases (TUXEDO-2) Recruiting AUT 0
NCT04484142 Phase II Datopotamab deruxtecan Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05) Active, not recruiting USA | NLD | ITA | FRA | ESP | DEU 4
NCT03401385 Phase I Datopotamab deruxtecan First-in-human Study of DS-1062a for Advanced Solid Tumors Recruiting USA 1
NCT04940325 Phase II Datopotamab deruxtecan Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer (ICARUS-LUNG01) Recruiting FRA 0
NCT06103864 Phase III Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan Carboplatin + Gemcitabine + Pembrolizumab A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | AUS 15
NCT05489211 Phase II Capecitabine + Datopotamab deruxtecan AZD5305 + Datopotamab deruxtecan + Durvalumab Capecitabine + Datopotamab deruxtecan + Nivolumab Carboplatin + Datopotamab deruxtecan Datopotamab deruxtecan + Fluorouracil AZD5305 + Datopotamab deruxtecan Datopotamab deruxtecan + Durvalumab Datopotamab deruxtecan + Fluorouracil + Nivolumab Bevacizumab + Datopotamab deruxtecan + Fluorouracil + Leucovorin Bevacizumab + Capecitabine + Datopotamab deruxtecan Datopotamab deruxtecan Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN 7
NCT05374512 Phase III Eribulin Nab-paclitaxel Paclitaxel Datopotamab deruxtecan Carboplatin Capecitabine A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy Recruiting USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL 15


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