Study identifier:D926UC00001
ClinicalTrials.gov identifier:NCT05489211
EudraCT identifier:2022-000776-19
CTIS identifier:2023-509436-26-00
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
endometrial cancer
Phase 2
No
Datopotamab deruxtecan (Dato-DXd), Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin, Leucovorin LV, Bevacizumab, Rilvegostomig, Prednisone/ prednisolone, Cisplatin
All
582
Interventional
18 Years - 130 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jul 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo
No locations available
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-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-3A Dato-DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
Experimental: Substudy-3C Dato-DXd will be evaluated in combination with prednisone/prednisolone | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Prednisone/ prednisolone Administered orally Other Name: Prednisolone |
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-4C Dato-DXd in combination with carboplatin + bevacizumab followed by Dato-DXd + bevacizumab will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Carboplatin Administered as an IV Other Name: Paraplatin Drug: Bevacizumab Administered as an IV Other Name: Avastin |
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 |
Experimental: Substudy-6A Dato-DXd in combination with volrustomig (MEDI5752) will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Volrustomig Administered as an IV Other Name: MEDI5752 |
Experimental: Substudy-6B Data-DXd in combination with rilvegostomig (AZD2936) will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Rilvegostomig Administered as an IV Other Name: AZD2936 |
Experimental: Substudy-6C Dato-DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |
Experimental: Substudy-6D Dato-DXd in combination with carboplatin or cisplatin will be evaluated | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a Drug: Carboplatin Administered as an IV Other Name: Paraplatin Drug: Cisplatin Administered as an IV Other Name: Platinol |
Experimental: Substudy-7A Dato-DXd will be evaluated as monotherapy | Drug: Datopotamab deruxtecan (Dato-DXd) Intravenous (IV) Antibody drug conjugate Other Name: DS-1062a |