Barrio De Torrejon

Researchers are evaluating MDNA11, a long-acting beta-only recombinant interleukin-2 designed to activate immune cells that kill cancer while minimizing activation of immunosuppressive cells. This Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with the checkpoint inhibitor pembrolizumab in patients with advanced solid tumors. The study is conducted at multiple sites with regulatory and ethical approvals and includes about 115 patients. The trial has several parts dose escalation and expansion for MDNA11 monotherapy and for its combination with pembrolizumab. MDNA11 is given intravenously every two weeks with doses adjusted to find the recommended dose for expansion. Tumor assessments using CT or MRI scans happen every 8 weeks to monitor response until disease progression or other study-end criteria occur. Treatment may continue beyond progression under certain conditions. Participants undergo evaluations including tumor imaging, laboratory tests, and safety monitoring over up to 24 months. Researchers measure recommended dose levels, treatment-related adverse events, pharmacokinetics, immune response, and anti-tumor activity such as response rates and progression-free survival. Patients can withdraw anytime, and safety follow-up continues to understand MDNA11s effects alone and with pembrolizumab.

Researchers are evaluating the use of angiogenic markers sFlt-1PlGF ratio to manage delivery timing in women with preeclampsia without severe features between 36 and 386 weeks of pregnancy. The study aims to see if basing delivery decisions on these markers can reduce the need for labor induction without increasing the risk of developing severe preeclampsia or other maternal complications. This is an open-label, randomized controlled trial sponsored by Hospital Universitari Vall dHebron Research Institute. Participants are randomly assigned to one of two groups. In the intervention group, if angiogenic markers are normal sFlt-1PlGF <38, delivery is delayed until 39 weeks if abnormal sFlt-1PlGF 38, labor induction is recommended at or after 37 weeks. The control group receives the current standard care with elective delivery scheduled at 37 weeks. Both groups have NT-proBNP levels measured at enrollment, and delivery is immediately recommended if any urgent maternal or fetal conditions arise. During the study, participants complete satisfaction questionnaires at enrollment and four weeks postpartum. Researchers monitor maternal and neonatal outcomes, including complications, ICU admissions, gestational age at delivery, birthweight, and maternal NT-proBNP levels. The primary outcome is a composite of maternal health measures assessed through about two months after delivery. The study is expected to last until April 2028.