Phase II Study of Datopotamab Deruxtecan Alone and With Other Cancer Medicines for Advanced or Metastatic Solid Tumors Including Various Cancer Types

What this Trial Is About

Researchers are evaluating the safety, tolerability, and anti-tumor activity of Datopotamab Deruxtecan Dato-DXd alone and combined with other anticancer agents in patients with advanced or metastatic solid tumors. This Phase II, open-label, multicenter study uses a master protocol with independent substudies focused on different tumor types including endometrial, gastric, prostate, ovarian, colorectal, urothelial, and biliary tract cancers. The study aims to find the recommended Phase II dose and assess efficacy and safety across these varied cancers. Participants receive Dato-DXd as monotherapy or in combination with approved or novel anticancer drugs depending on their specific cancer type and substudy assignment. Treatments include intravenous Dato-DXd alone or combined with agents such as capecitabine, 5-Fluorouracil, prednisoneprednisolone, carboplatin, bevacizumab, volrustomig, rilvegostomig, or cisplatin. The study allows evaluation of various combinations across substudies to understand the drugs role in different cancer settings. During the study, participants undergo regular assessments including tumor measurements, safety evaluations, blood tests for pharmacokinetics and immune response, and specific cancer marker tests like PSA or CA-125 depending on cancer type. Researchers measure outcomes such as objective response rate, progression-free survival, duration of response, and adverse events over approximately one year. Safety follow-up occurs after treatment ends, and participants are monitored closely throughout their involvement, which lasts about one year from treatment start.

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)