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Found 2 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating MDNA11, a long-acting "beta-only" recombinant interleukin-2 designed to activate immune cells that attack cancer while minimizing stimulation of cells that suppress immunity. This Phase 1/2 open-label study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early anti-tumor activity of MDNA11 alone or combined with pembrolizumab in patients with advanced or metastatic solid tumors. The study includes dose-escalation and dose-expansion parts for both monotherapy and combination therapy with pembrolizumab. MDNA11 is given intravenously every two weeks with doses ranging from 0.003 to 0.6 mg/kg for monotherapy, while dose ranges for combination therapy are also evaluated. Treatment continues until progression, withdrawal, or loss to follow-up, with tumor assessments by CT or MRI every 8 weeks. Participants will undergo regular imaging scans every 8 weeks to monitor tumor response and safety assessments throughout the 24-month study. Researchers will track recommended doses for expansion, treatment-related adverse events, and overall safety. The study involves up to 115 patients across multiple sites and includes long-term monitoring for up to 24 months.
Actively Recruiting
Researchers are evaluating whether managing delivery based on angiogenic factors (sFlt-1/PlGF) in women with preeclampsia without severe features can reduce the need for labor induction without increasing severe maternal complications. This study focuses on pregnant women between 36 and 38 weeks plus 6 days, comparing a new approach to the current standard care. The trial is open-label and randomized to assess maternal outcomes by the end of the study, approximately two months after delivery. Participants are randomly divided into two groups. In the study group, if angiogenic factor levels are normal (sFlt-1/PlGF less than 38), delivery is delayed until 39 weeks unless other medical conditions require earlier delivery. If angiogenic factors are abnormal (sFlt-1/PlGF 38 or higher), labor is induced at or after 37 weeks. The control group follows standard care with labor recommended at 37 weeks. Both groups have NT-proBNP blood levels measured at enrollment and complete satisfaction questionnaires at enrollment and four weeks post-delivery. Immediate delivery is recommended within 24 hours if severe preeclampsia or other fetal concerns arise. Participants will be monitored through medical assessments including Doppler ultrasound of the umbilical artery and fetal well-being tests. Researchers will evaluate maternal outcomes, progression to severe preeclampsia, fetal health, and patient satisfaction. The main outcome measured is a composite of maternal health events throughout the study period, which lasts about two months after delivery. This includes close clinical observation for any worsening of the condition or complications.