Mount Pleasant

This trial is designed for adults diagnosed with metastatic pancreatic ductal adenocarcinoma PDAC who have not yet received systemic treatment for their advanced cancer and have a good performance status. The study evaluates pumitamig, an investigational drug, in combination with chemotherapy to assess its safety and effectiveness. This phase II trial plans to explore different chemotherapy regimens combined with pumitamig to understand their impact on the disease.

Researchers are evaluating the safety, how the body processes and reacts to, and the early effects of ATG-037 alone and combined with Pembrolizumab in adults with locally advanced or metastatic solid tumors. This Phase I study aims to find the best dose and understand treatment impacts on patients whose cancer has progressed despite prior immune checkpoint inhibitor therapy. The trial is open-label, meaning both researchers and participants know the treatments being given, and it includes multiple centers to gather diverse data. The study has two main parts Part I involves dose escalation of ATG-037 given orally once daily initially, then twice daily in cycles of 21 days, followed by combination therapy with Pembrolizumab administered every three weeks for up to about two years. Part II explores ATG-037 given twice daily from the start in combination with Pembrolizumab. Pembrolizumab is given as a fixed 200 mg dose every three weeks. The study includes dose escalation and expansion phases to evaluate different dosing and combinations. Participants will undergo regular monitoring including safety evaluations for adverse events up to one year after the last dose. Researchers will measure drug levels in plasma, immune activity markers, and tumor responses using standard criteria. The study assesses outcomes like dose-limiting toxicities, maximum tolerated dose, and response rates to understand treatment effects. Participants are expected to provide informed consent, meet specific health criteria, and participate in scheduled visits and assessments throughout the treatment and follow-up periods.

Researchers are evaluating patritumab deruxtecan MK-1022 as a treatment for advanced gastrointestinal cancers, including unresectable or metastatic colorectal cancer, biliary tract cancer, hepatocellular carcinoma, and gastroesophageal cancer. This study aims to learn about the safety and tolerability of patritumab deruxtecan and to see how many participants experience their cancer shrinking or disappearing in response to the treatment. Participants receive patritumab deruxtecan through an intravenous infusion on the first day of every 21-day cycle. Treatment continues until the cancer progresses, side effects become intolerable, or the investigator decides to stop. The study includes a dose-escalation phase to evaluate safety and further phases to assess treatment efficacy over time. During the trial, participants will be monitored for dose-limiting toxicities, adverse events, and reasons for discontinuing treatment. Researchers will measure the objective response rate, duration of response, progression-free survival, overall survival, and drug concentration levels in the blood. The study may last up to approximately 44 months, with ongoing assessments to understand the treatments effects and safety.