Vaillant

Researchers are studying a protein called Claudin 18.2 (CLDN18.2) found on digestive system cells and some tumors, including those in stomach, gastroesophageal junction (GEJ), and pancreatic cancers. The trial evaluates ASP2138, a treatment designed to bind to CLDN18.2 and activate the immune system's T-cells to attack tumors. This phase 1/1b study aims to determine the safety, tolerability, and appropriate dosing of ASP2138 given alone or combined with standard treatments for these cancers. During the first phase, participants receive increasing doses of ASP2138 either intravenously or by injection under the skin. ASP2138 is administered alone or with one of three standard therapies: pembrolizumab with mFOLFOX6 for gastric/GEJ cancer as first-line treatment, ramucirumab with paclitaxel as second-line treatment for gastric/GEJ cancer, or mFOLFIRINOX for pancreatic cancer. The second phase uses doses identified from phase 1 and continues treatment with ASP2138 alone or in combination, depending on cancer type and prior therapy. The study includes an end-of-treatment visit 7 days after the last dose or if treatment is stopped early. Participants, age 18 and older with locally advanced unresectable or metastatic gastric, GEJ, or pancreatic cancers expressing CLDN18.2, will undergo regular monitoring including scans and lab tests to evaluate safety and side effects. Researchers track adverse events, vital signs, ECG results, physical exams, and performance status for up to 27 months. The study helps determine how the body processes ASP2138 and the potential medical issues from treatment, supporting future use and dosing recommendations.

Researchers are evaluating the safety and effectiveness of a new oral drug called daraxonrasib compared to the chemotherapy drug docetaxel in patients with non-small cell lung cancer (NSCLC) that has a specific RAS mutation. This Phase 3 global study focuses on patients whose cancer has locally advanced or spread and who have already received prior treatments. The goal is to see if daraxonrasib can improve the time patients live without their cancer worsening and overall survival. Participants will be randomly assigned to receive either daraxonrasib tablets taken by mouth or docetaxel given by intravenous infusion. The study is open-label, meaning both doctors and patients know which treatment is given. Treatment continues as long as it is appropriate, and patients are monitored throughout the study period. During the trial, patients will undergo regular assessments to measure disease progression and survival up to about four years. Researchers will evaluate progression-free survival and overall survival as the main outcomes. Patients must have measurable disease and meet health criteria, and their RAS mutation status will be confirmed. Safety and effectiveness will be closely monitored throughout the study.