Pamukkale

Researchers are evaluating the safety, tolerability, and anti-tumor activity of Datopotamab Deruxtecan (Dato-DXd) as both a single treatment and combined with other anticancer agents in patients with various advanced or metastatic solid tumors. This Phase II, open-label, multicenter study uses a master protocol with independent substudies to study different tumor types, including endometrial, gastric, metastatic castration-resistant prostate, ovarian, colorectal, urothelial, and biliary tract cancers. The study aims to find the recommended Phase II dose, assess safety, and evaluate treatment effectiveness across these cancer types. Dato-DXd will be given as an intravenous antibody drug conjugate, either alone or combined with other approved or novel anticancer drugs depending on the tumor type. The combinations vary by substudy, with monotherapy tested in all but one group and combination therapies in all but two groups. The study interventions include drugs administered orally or intravenously, such as Capecitabine, 5-Fluorouracil, Volrustomig, Carboplatin, Bevacizumab, Rilvegostomig, Prednisone/prednisolone, and Cisplatin. Participants will be monitored for response to treatment, including objective response rate, progression-free survival, and adverse events over approximately one year. Those in the prostate cancer substudy will have specific PSA response assessments. Safety follow-up occurs for up to 28 or 90 days after stopping treatments, depending on the drug. Researchers will collect tissue samples, perform regular clinical assessments, and track participants' health status, tumor changes, and side effects throughout the study period.

Researchers are evaluating the effectiveness of ravulizumab compared to a placebo in reducing proteinuria and improving kidney function in adults with Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression. This Phase 3 study involves participants who have a confirmed diagnosis of IgAN and are receiving stable standard treatments for their condition. The study aims to provide important information about the impact of ravulizumab on kidney health over time. About 510 eligible participants will join the study. Around 450 will be randomly assigned to receive either ravulizumab or a placebo through weight-based intravenous infusions. Participants will continue their stable IgAN treatments during the study. An additional group of approximately 60 participants with more advanced kidney disease will also be enrolled. After Week 106, all participants have the option to enter an open-label phase to receive ravulizumab. Participants will be monitored through urine tests measuring protein levels and kidney function assessments over the course of the study. Key outcomes include changes in proteinuria at Week 34 and kidney filtration rate at Week 106. Safety and treatment effects will be closely observed throughout the study and during any extended access periods. The study includes thorough screening and follow-up assessments to track progress and ensure participant well-being.