Study of Dato-Dxd as monotherapy and in combination with anti-cancer agents in patients with advanced solid Tumours (TROPION-PanTumor03)
Study identifier:D926UC00001
ClinicalTrials.gov identifier:NCT05489211
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
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)
Medical condition
endometrial cancer
Phase
Phase 2
Healthy volunteers
No
Study drug
Datopotamab deruxtecan (Dato-DXd), AZD5305, Durvalumab, Capecitabine, 5-Fluorouracil, Nivolumab, Carboplatin, Leucovorin LV, Bevacizumab
Sex
All
Estimated Enrollment
531
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 06 Sept 2022
Estimated Primary Completion Date: 31 Mar 2025
Estimated Study Completion Date: 31 Mar 2025
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Daiichi Sankyo
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Substudy-1A Dato-DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
| Experimental: Substudy-1B Dato-Dxd in combination with Durvalumab will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Durvalumab Administered as an IV Other Name: MEDI4736 Other Name: IMFINZI |
| Experimental: Substudy-1C Dato-Dxd in combination with AZD5305 will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
| Experimental: Substudy-1D Dato-Dxd in combination with Durvalumab + AZD5305 will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: AZD5305 Oral poly ADP ribose polymerase (PARP) inhibitor Drug: Durvalumab Administered as an IV Other Name: MEDI4736 Other Name: IMFINZI |
| Experimental: Substudy-2A Dato-DXd in combination with capecitabine will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Capecitabine Administered orally Other Name: Xeloda |
| Experimental: Substudy-2B Dato-DXd in combination with 5-FU will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: 5-Fluorouracil Administered as an IV Other Name: Adrucil |
| Experimental: Substudy-2C Dato-DXd in combination with chemotherapy (capecitabine or 5-FU) + nivolumab will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Capecitabine Administered orally Other Name: Xeloda Drug: 5-Fluorouracil Administered as an IV Other Name: Adrucil Drug: Nivolumab Administered as an IV Other Name: OPDIVO |
| Experimental: Substudy-3A Dato-DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
| Experimental: Substudy-3B Dato-DXd in combination with AZD5305 will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: AZD5305 Oral poly ADP ribose polymerase (PARP) inhibitor |
| Experimental: Substudy-4A Dato DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
| Experimental: Substudy-4B Dato-DXd in combination with carboplatin and Dato-DXd + AZD5305 will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: AZD5305 Oral poly ADP ribose polymerase (PARP) inhibitor Drug: Carboplatin Administered as an IV Other Name: Paraplatin |
| Experimental: Substudy-5A Dato-DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
| Experimental: Substudy-5B Dato-DXd + 5-FU + LV + bevacizumab OR Dato-DXd + capecitabine + bevacizumab will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Capecitabine Administered orally Other Name: Xeloda Drug: 5-Fluorouracil Administered as an IV Other Name: Adrucil Drug: Leucovorin LV Administered as an IV Other Name: Folinic acid Drug: Bevacizumab Administered as an IV Other Name: Avastin |
Contacts
Investigators
Principal Investigator
Yelena Janjigian
Rockefeller Outpatient Pavilion
