Cipolletti

Researchers are evaluating the safety and tolerability of Mocertatug Rezetecan in adults with advanced solid tumors, including platinum-resistant ovarian cancer and endometrial cancer. The study aims to observe how levels of Mocertatug Rezetecan change over time at different doses. Participants have tumors that have not responded to or cannot tolerate standard treatments. The study includes two parts dose escalation and dose expansion, both involving administration of Mocertatug Rezetecan as an injection. Participants receive varying doses to determine safety, tolerability, and clinical activity. Tissue samples will be collected for biomarker analysis, including expression of B7-H4. The study may last up to approximately 31 months depending on the part and participant response. Participants will undergo regular assessments including evaluation of tumor response using standard criteria, monitoring of blood and urine tests, vital signs, ECGs, and other laboratory measures. Safety is closely monitored through tracking adverse events and specific toxicity markers. The main outcomes measured include dose limiting toxicities in the first 21 days and objective response rates over about 28 months. Follow-up evaluations continue for safety and clinical activity throughout the study.

Researchers are evaluating how a new combination treatment of Sigvotatug Vedotin plus pembrolizumab works compared to pembrolizumab alone in adults with non-small cell lung cancer NSCLC who have high levels of the PD-L1 protein. This protein can limit the bodys immune response to cancer. The study includes participants with advanced NSCLC who meet specific molecular and staging criteria and aims to assess the treatments effects on survival and disease progression. Participants receive pembrolizumab as an intravenous infusion once every 6 weeks at the clinic. Half of the participants will also receive Sigvotatug Vedotin intravenously every 2 weeks alongside pembrolizumab. Pembrolizumab treatment may continue for up to about two years, whereas Sigvotatug Vedotin administration can continue until the cancer no longer responds. The trial is randomized and controlled, comparing the combination treatment to pembrolizumab alone. During the study, participants attend regular clinic visits for treatment and monitoring. Researchers will evaluate overall survival and progression-free survival over approximately two years, along with additional measures such as response rates, duration of response, safety, and drug levels in the blood. The study includes ongoing assessments to observe how participants respond to treatment and manage side effects, with a total participation time that may extend up to several years.