Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ZOYQV
ADC Name
Datopotamab deruxtecan
Synonyms
DS 1062a; DS-1062; DS-1062a; Dato-DXd
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Organization
Daiichi Sankyo Co., Ltd.; AstraZeneca PLC; Baxter Oncology GmbH
Drug Status
Phase 3
Indication
In total 12 Indication(s)
Breast cancer [ICD11:2C60-2C65]
Phase 3
HER2(+) breast cancer [ICD11:2C60-2C65]
Phase 3
Non-small cell lung cancer [ICD11:2C25]
Phase 3
Triple negative breast cancer [ICD11:2C60-2C65]
Phase 3
Colorectal cancer [ICD11:2B91]
Phase 2
Endometrial cancer [ICD11:2C76]
Phase 2
Ovarian cancer [ICD11:2C73]
Phase 2
Prostate cancer [ICD11:2C82]
Phase 2
Solid tumors [ICD11:2A00-2A0Z|2B50-2F9Z]
Phase 2
Urothelial cancer [ICD11:2C9Z]
Phase 2
Esophageal cancer [ICD11:2B70]
Phase 1
Small cell lung cancer [ICD11:2C25]
Phase 1
Drug-to-Antibody Ratio
4
Structure
Antibody Name
Datopotamab
  Antibody Info 
Antigen Name
Tumor-associated calcium signal transducer 2 (TACSTD2)
  Antigen Info 
Payload Name
DX-8951 derivative (DXd)
  Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
  Target Info 
Linker Name
Mc-Gly-Gly-Phe-Gly
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
Deruxtecan
Puchem SID
472421347 , 405023086 , 404719861
Drugbank ID
DB16410
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 22 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT03401385
Phase 1/2
Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Objective Response Rate (ORR)  NCT03742102
Phase 1/2
A phase 1b/2, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab (MEDI4736) + paclitaxel and durvalumab (MEDI4736) in combination with novel oncology therapies with or without paclitaxel for first-line metastatic triple negative breast cancer.

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Objective Response Rate (ORR)  NCT03401385
Phase 1
Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Objective Response Rate (ORR)  NCT03401385
Phase 1
Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Objective Response Rate (ORR)  NCT03401385
Phase 1
Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Objective Response Rate (ORR)  NCT04526691
Phase 1
Phase 1b, multicenter, open-label study of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in subjects with advanced or metastatic non-small cell lung cancer (TROPION-Lung02).

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Undisclosed  NCT05687266
Phase 3
A phase 3, randomised, open-label, multicentre, global study of datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin versus pembrolizumab in combination with platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC without actionable genomic alterations (D926NC00001; AVANZAR).

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Undisclosed  NCT05629585
Phase 3
A phase 3 open-label, randomised study of datopotamab deruxtecan (DatoDXd) with or without durvalumab versus investigator's choice of therapy in patients with stage i-2i triple-negative breast cancer who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy (TROPION-Breast03).

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Undisclosed  NCT05555732
Phase 3
A randomized phase 3 study of datopotamab deruxtecan (Dato-DXd) and pembrolizumab with or without platinum chemotherapy in subjects with no prior therapy for advanced or metastatic PD-L1 TPS <50% non-squamous non-small cell lung cancer without actionable genomic alterations (TROPION-Lung07).

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Undisclosed  NCT05374512
Phase 3
A phase 3, open-label, randomised study of datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy in patients who are not candidates for PD-1/PD-L1 inhibitor therapy in first-line locally recurrent inoperable or metastatic triple-negative breast cancer (TROPION Breast02).

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Undisclosed  NCT05215340
Phase 3
A randomized, open-label, phase 3 trial of Dato-DXd plus pembrolizumab vs pembrolizumab alone in treatment-nave subjects with advanced or metastatic PD-L1 high (TPS 50%) non-small cell lung cancer without actionable genomic alterations (TROPION-Lung08).

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Undisclosed  NCT05104866
Phase 3
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).

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Undisclosed  NCT04656652
Phase 3
Phase 3 randomized study of DS-1062a versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (TROPION-LUNG01).
Undisclosed  NCT05489211
Phase 2
A phase 2, multicentre, open-label, master protocol to evaluate the efficacy and safety of datopotamab deruxtecan (Dato-DXd) as monotherapy and in combination with anticancer agents in patients with advanced/metastatic solid tumours (TROPION-PanTumor03).

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Undisclosed  NCT05061550
Phase 2
A phase 2, open-label, multicentre, randomised study of neoadjuvant and adjuvant treatment in patients with resectable, early-stage (2 to 2IB) non-small cell lung cancer (NeoCOAST-2).
Undisclosed  NCT04940325
Phase 2
Phase 2, open label study of DS-1062a, an anti-TROP-2-antibody-drug conjugate (ADC), in patients with advanced and/or unresectable non-small cell lung cancer (NSCLC), with biomarker analysis to characterize response to therapy.

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Undisclosed  NCT04484142
Phase 2
Phase 2, single-arm, open-label study of DS-1062A in advanced or metastatic non-small cell lung cancer with actionable genomic alterations and progressed on or after applicable targeted therapy and platinum based chemotherapy (TROPION-Lung05).

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Undisclosed  NCT03944772
Phase 2
A biomarker-directed phase 2 platform study in patients with advanced non-small lung cancer whose disease has progressed on first-line osimertinib therapy.
Undisclosed  NCT01042379
Phase 2
I-SPY trial (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2).
Undisclosed  NCT05460273
Phase 1/2
Phase 1/2, multicentre, open-label, multiple-cohort study of Dato-DXd in Chinese patients with advanced non-small-cell lung cancer, triple-negative breast cancer, gastric/gastroesophageal junction cancer, urothelial cancer, and other solid tumours (TROPION-PanTumor02).

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Undisclosed  NCT04644068
Phase 1
A modular phase 1/2a, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of ascending doses of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies.

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Undisclosed  NCT04612751
Phase 1
A phase 1b, multicenter, 2-part, open-label study of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (Tropion-Lung04).

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Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type Value Units Cell Line Disease Model
Tumor Growth Inhibition value (TGI) 
≈ 96
%
NCI-N87 cells
Gastric tubular adenocarcinoma
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 22 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
24.00% (NSCLC, 4 mg/kg)
26.00% (NSCLC, 6 mg/kg)
24.00% (NSCLC, 8 mg/kg)
39.00% (TNBC, 6 mg/kg)
Patients Enrolled
Patients were unselected for TROP2 expression and had measurable disease per RECIST version 1.1; patients with stable/treated brain metastases were permitted.
Administration Dosage
Dato-DXd 4 mg/kg (n=50), 6 mg/kg (n=50), or 8 mg/kg (n=80) intravenously every 3 weeks.
Related Clinical Trial
NCT Number NCT03401385  Clinical Status Phase 1/2
Clinical Description Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Objective Response Rate (ORR)
34.00
52.00% (in a subset nave to TOPO I-based ADCs)
Patients Enrolled
Unresectable a/mTNBC pts eligible for 1L treatment, regardless of PD-L1/TROP2 status.
Administration Dosage
Intravenous Dato-DXd 6 mg/kg + durvalumab 1120 mg every 3 weeks.
Related Clinical Trial
NCT Number NCT03742102  Clinical Status Phase 1/2
Clinical Description A phase 1b/2, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab (MEDI4736) + paclitaxel and durvalumab (MEDI4736) in combination with novel oncology therapies with or without paclitaxel for first-line metastatic triple negative breast cancer.
Experiment 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR) 22.00% High TROP2 expression (TROP2 +++)
Patients Enrolled
Two hundred ten adults with locally advanced/metastatic non-small cell lung cancer (NSCLC).
Administration Dosage
0.27-10 mg/kg Dato-DXd once every 3 weeks during escalation or 4 mg/kg Dato-DXd once every 3 weeks during expansion.
Related Clinical Trial
NCT Number NCT03401385  Clinical Status Phase 1
Clinical Description Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Experiment 4 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR) 23.80% High TROP2 expression (TROP2 +++)
Patients Enrolled
Two hundred ten adults with locally advanced/metastatic non-small cell lung cancer (NSCLC).
Administration Dosage
0.27-10 mg/kg Dato-DXd once every 3 weeks during escalation or 8 mg/kg Dato-DXd once every 3 weeks during expansion.
Related Clinical Trial
NCT Number NCT03401385  Clinical Status Phase 1
Clinical Description Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Experiment 5 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR) 26.00% High TROP2 expression (TROP2 +++)
Patients Enrolled
Two hundred ten adults with locally advanced/metastatic non-small cell lung cancer (NSCLC).
Administration Dosage
0.27-10 mg/kg Dato-DXd once every 3 weeks during escalation or 6 mg/kg Dato-DXd once every 3 weeks during expansion.
Related Clinical Trial
NCT Number NCT03401385  Clinical Status Phase 1
Clinical Description Phase 1, two-part, multicenter, open-label, multiple dose, first-in-human study of DS-1062a in subjects with advanced solid tumors (TROPION-PanTumor01).
Primary Endpoint
Patients receiving 6 mg/kg (n = 50), median duration on study, including follow-up, and median exposure were 13.30 and 3.50 months, respectively. The most frequent any-grade treatment-emergent adverse events (TEAEs) were nausea (64.00%), stomatitis (60.00%), and alopecia (42.00%).
Experiment 6 Reporting the Activity Date of This ADC [4]
Efficacy Data Objective Response Rate (ORR)
50.00% (doublet)
57.00% (triplet)
Patients Enrolled
Pts in escalation may have received 2 prior lines of therapy for a non-small cell lung cancer (NSCLC). Pts in expansion were primarily treatment (tx) naive (pts receiving Dato-DXd + pembro may have 1 prior Pt-based tx).
Administration Dosage
Dato-DXd (4 or 6 mg/kg) + pembro 200 mg Pt-CT (cisplatin 75 mg/m2 or carboplatin AUC 5) every 21 days across 6 cohorts.
Related Clinical Trial
NCT Number NCT04526691  Clinical Status Phase 1
Clinical Description Phase 1b, multicenter, open-label study of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy in subjects with advanced or metastatic non-small cell lung cancer (TROPION-Lung02).
Experiment 7 Reporting the Activity Date of This ADC [5]
Related Clinical Trial
NCT Number NCT05687266  Clinical Status Phase 3
Clinical Description A phase 3, randomised, open-label, multicentre, global study of datopotamab deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin versus pembrolizumab in combination with platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic NSCLC without actionable genomic alterations (D926NC00001; AVANZAR).
Experiment 8 Reporting the Activity Date of This ADC [6]
Related Clinical Trial
NCT Number NCT05629585  Clinical Status Phase 3
Clinical Description A phase 3 open-label, randomised study of datopotamab deruxtecan (DatoDXd) with or without durvalumab versus investigator's choice of therapy in patients with stage i-2i triple-negative breast cancer who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy (TROPION-Breast03).
Experiment 9 Reporting the Activity Date of This ADC [7]
Patients Enrolled
Patients with previously untreated, advanced or metastatic non-squamous NSCLC with less than 50% programmed death-ligand (PD-L1) expression (tumor proportion score [TPS] < 50%) and without actionable genomic alterations.
Administration Dosage
Arm A (datopotamab deruxtecan [6 mg/kg] plus pembrolizumab 200 mg IV plus platinum chemotherapy every three weeks), Arm B (datopotamab deruxtecan [6 mg/kg] plus pembrolizumab 200 mg IV every three weeks), and Arm C (pembrolizumab 200 mg IV plus pemetrexed [500 mg/m2] plus platinum chemotherapy every three weeks).
Related Clinical Trial
NCT Number NCT05555732  Clinical Status Phase 3
Clinical Description A randomized phase 3 study of datopotamab deruxtecan (Dato-DXd) and pembrolizumab with or without platinum chemotherapy in subjects with no prior therapy for advanced or metastatic PD-L1 TPS <50% non-squamous non-small cell lung cancer without actionable genomic alterations (TROPION-Lung07).
Experiment 10 Reporting the Activity Date of This ADC [8]
Related Clinical Trial
NCT Number NCT05374512  Clinical Status Phase 3
Clinical Description A phase 3, open-label, randomised study of datopotamab deruxtecan (Dato-DXd) versus investigator's choice of chemotherapy in patients who are not candidates for PD-1/PD-L1 inhibitor therapy in first-line locally recurrent inoperable or metastatic triple-negative breast cancer (TROPION Breast02).
Experiment 11 Reporting the Activity Date of This ADC [9]
Patients Enrolled
Advanced non-small cell lung cancer (NSCLC).
Administration Dosage
Dato-DXd 6 mg/kg plus pembrolizumab 200 mg every 3 weeks (arm 1) and pembrolizumab 200 mg every 3 weeks (arm 2).
Related Clinical Trial
NCT Number NCT05215340  Clinical Status Phase 3
Clinical Description A randomized, open-label, phase 3 trial of Dato-DXd plus pembrolizumab vs pembrolizumab alone in treatment-nave subjects with advanced or metastatic PD-L1 high (TPS 50%) non-small cell lung cancer without actionable genomic alterations (TROPION-Lung08).
Experiment 12 Reporting the Activity Date of This ADC [10]
Patients Enrolled
Patients with inoperable or metastatic HR+/HER2 breast cancer.
Administration Dosage
Dato-DXd 6 mg/kg IV Q3W or ICC (eribulin, capecitabine, vinorelbine, or gemcitabine).
Related Clinical Trial
NCT Number NCT05104866  Clinical Status Phase 3
Clinical Description 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).
Experiment 13 Reporting the Activity Date of This ADC [11]
Related Clinical Trial
NCT Number NCT04656652  Clinical Status Phase 3
Clinical Description Phase 3 randomized study of DS-1062a versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (TROPION-LUNG01).
Experiment 14 Reporting the Activity Date of This ADC [12]
Related Clinical Trial
NCT Number NCT05489211  Clinical Status Phase 2
Clinical Description A phase 2, multicentre, open-label, master protocol to evaluate the efficacy and safety of datopotamab deruxtecan (Dato-DXd) as monotherapy and in combination with anticancer agents in patients with advanced/metastatic solid tumours (TROPION-PanTumor03).
Experiment 15 Reporting the Activity Date of This ADC [13]
Related Clinical Trial
NCT Number NCT05061550  Clinical Status Phase 2
Clinical Description A phase 2, open-label, multicentre, randomised study of neoadjuvant and adjuvant treatment in patients with resectable, early-stage (2 to 2IB) non-small cell lung cancer (NeoCOAST-2).
Experiment 16 Reporting the Activity Date of This ADC [14]
Related Clinical Trial
NCT Number NCT04940325  Clinical Status Phase 2
Clinical Description Phase 2, open label study of DS-1062a, an anti-TROP-2-antibody-drug conjugate (ADC), in patients with advanced and/or unresectable non-small cell lung cancer (NSCLC), with biomarker analysis to characterize response to therapy.
Experiment 17 Reporting the Activity Date of This ADC [15]
Related Clinical Trial
NCT Number NCT04484142  Clinical Status Phase 2
Clinical Description Phase 2, single-arm, open-label study of DS-1062A in advanced or metastatic non-small cell lung cancer with actionable genomic alterations and progressed on or after applicable targeted therapy and platinum based chemotherapy (TROPION-Lung05).
Experiment 18 Reporting the Activity Date of This ADC [16]
Related Clinical Trial
NCT Number NCT03944772  Clinical Status Phase 2
Clinical Description A biomarker-directed phase 2 platform study in patients with advanced non-small lung cancer whose disease has progressed on first-line osimertinib therapy.
Experiment 19 Reporting the Activity Date of This ADC [17]
Related Clinical Trial
NCT Number NCT01042379  Clinical Status Phase 2
Clinical Description I-SPY trial (investigation of serial studies to predict your therapeutic response with imaging and molecular analysis 2).
Experiment 20 Reporting the Activity Date of This ADC [18]
Related Clinical Trial
NCT Number NCT05460273  Clinical Status Phase 1/2
Clinical Description Phase 1/2, multicentre, open-label, multiple-cohort study of Dato-DXd in Chinese patients with advanced non-small-cell lung cancer, triple-negative breast cancer, gastric/gastroesophageal junction cancer, urothelial cancer, and other solid tumours (TROPION-PanTumor02).
Experiment 21 Reporting the Activity Date of This ADC [19]
Related Clinical Trial
NCT Number NCT04644068  Clinical Status Phase 1
Clinical Description A modular phase 1/2a, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of ascending doses of AZD5305 as monotherapy and in combination with anti-cancer agents in patients with advanced solid malignancies.
Experiment 22 Reporting the Activity Date of This ADC [20]
Related Clinical Trial
NCT Number NCT04612751  Clinical Status Phase 1
Clinical Description A phase 1b, multicenter, 2-part, open-label study of datopotamab deruxtecan (Dato-DXd) in combination with immunotherapy with or without carboplatin in participants with advanced or metastatic non-small cell lung cancer (Tropion-Lung04).
Discovered Using Cell Line-derived Xenograft Model
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [21]
Efficacy Data Tumor Growth Inhibition value (TGI) ≈ 96.00% (Day 21) High TROP2 expression (TROP2+++)
Method Description
Dato-DXd was intravenously administered at 10 mg/kg to NCI-N87 xenograft model mice. When the tumor volume reached approximately 150-300 mm3,the tumor-bearing mice were assigned to the vehicle control group,the treatment groups and the satellite sampling groups,and Dato-DXd or other test substances were administered intravenously once on day 0.

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In Vivo Model NCI-N87 cell line xenograft model
In Vitro Model Gastric tubular adenocarcinoma NCI-N87 cells CVCL_1603
References
Ref 1 Datopotamab deruxtecan in advanced/metastatic HER2- breast cancer: Results from the phase 1 TROPION-PanTumor01 study. Cancer Res (2022) 82 (4_Supplement): GS1-05.
Ref 2 Datopotamab deruxtecan (Dato-DXd) + durvalumab (D) as first-line (1L) treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from BEGONIA, a phase Ib/II study. J Thorac Oncol. 2022 May; 33(3):Supplement S199.
Ref 3 First-in-Human, Phase I Dose-Escalation and Dose-Expansion Study of Trophoblast Cell-Surface Antigen 2-Directed Antibody-Drug Conjugate Datopotamab Deruxtecan in Non-Small-Cell Lung Cancer: TROPION-PanTumor01. J Clin Oncol. 2023 Jun 16:JCO2300059. doi: 10.1200/JCO.23.00059. Online ahead of print.
Ref 4 TROPION-Lung08: Phase III study of datopotamab deruxtecan plus pembrolizumab as first-line therapy for advanced NSCLC. Future Oncol. 2023 May 30. doi: 10.2217/fon-2023-0230.
Ref 5 A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR), NCT05687266
Ref 6 A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03), NCT05629585
Ref 7 A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07), NCT05555732
Ref 8 A Phase 3, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) Versus Investigator's Choice of Chemotherapy in Patients Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy in First-line Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION Breast02), NCT05374512
Ref 9 Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators choice of chemotherapy in previously-treated, inoperable or metastatic HR+/HER2 breast cancer: TROPION-Breast01. Cancer Res (2023) 83 (5_Supplement): OT1-03-04.
Ref 10 MA03.02 TROPION-PanTumor01: Updated Results From the NSCLC Cohort of the Phase 1 Study of Datopotamab Deruxtecan in Solid Tumors. J Thorac Oncol. 2021 Sept; 16(10):Supplement S892-S893.
Ref 11 Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01), NCT04656652
Ref 12 A Phase II, Multicentre, Open-label, Master Protocol to Evaluate the Efficacy and Safety of Datopotamab Deruxtecan (Dato-DXd) as Monotherapy and in Combination With Anticancer Agents in Patients With Advanced/Metastatic Solid Tumours (TROPION-PanTumor03), NCT05489211
Ref 13 A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2), NCT05061550
Ref 14 Phase 2, Open Label Study of DS-1062a, an Anti-TROP-2-Antibody-Drug Conjugate (ADC), in Patients With Advanced and/or Unresectable Non-Small Cell Lung Cancer (NSCLC), With Biomarker Analysis to Characterize Response to Therapy, NCT04940325
Ref 15 Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05), NCT04484142
Ref 16 A Biomarker-directed Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Whose Disease Has Progressed on First-Line Osimertinib Therapy. NCT03944772
Ref 17 I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2), NCT01042379
Ref 18 Phase 1/2, Multicentre, Open-label, Multiple-cohort Study of Dato-DXd in Chinese Patients With Advanced Non-small-cell Lung Cancer, Triple-negative Breast Cancer, Gastric/Gastroesophageal Junction Cancer, Urothelial Cancer, and Other Solid Tumours (TROPION-PanTumor02), NCT05460273
Ref 19 A Modular Phase I/IIa, Open-label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies, NCT04644068
Ref 20 A Phase 1b, Multicenter, 2-Part, Open-Label Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Immunotherapy With or Without Carboplatin in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (Tropion-Lung04), NCT04612751
Ref 21 Datopotamab Deruxtecan, a Novel TROP2-directed Antibody-drug Conjugate, Demonstrates Potent Antitumor Activity by Efficient Drug Delivery to Tumor Cells. Mol Cancer Ther. 2021 Dec;20(12):2329-2340.

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