![]() Substudy 5 (CRC) MONO and Dato-DXd + 5-FU + leucovorin (LV) + bevacizumab or Dato-DXd + capecitabine + bevacizumab ![]() Substudy 4 (Ovarian Cancer) MONO and Dato-DXd + carboplatin, Dato-DXd + AZD5305 Substudy 3 (mCRPC) MONO and Dato-DXd + AZD5305 Substudy 2 (Gastric Cancer) Dato-DXd + capecitabine, Dato-DXd + 5-fluorouracil (5-FU), Dato-DXd + chemotherapy (capecitabine or 5-FU) + nivolumab Substudy 1 (Endometrial Cancer) MONO: Dato-DXd monotherapy COMBO Dato-DXd + durvalumab, Dato-DXd + AZD5305, Dato-DXd + durvalumab +AZD5305 Substudy 2 (2A, 2B) will be randomised and other substudies will be assigned. Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2, Gastric Cancer) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated. ![]() Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Within each substudy, Dato-DXd will be evaluated as monotherapy (for all substudies except Substudy 2, (Gastric Cancer) and in combination with approved or novel anticancer agents that may be active in the tumour type being evaluated.(AZD5305, Durvalumab). This study will evaluate various solid tumour types, including endometrial cancer (Substudy 1), gastric cancer (Substudy 2), metastatic castration-resistant prostate cancer (mCRPC) (Substudy 3), ovarian cancer (Substudy 4), and colorectal cancer (CRC) (Substudy 5) in the advanced or metastatic setting. This study has a modular design, as such a master protocol with independent substudies enables simultaneous evaluation of the safety profile, recommended Phase II dose (RP2D), and efficacy of Dato-DXd in multiple disease populations and treatment combinations. This Phase II, open-label, uncontrolled, multicentre study evaluating the efficacy and safety of Dato-DXd as monotherapy (MONO) and in combination with anticancer agents (COMBO) in various advanced solid tumour types. Why Should I Register and Submit Results?.
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