Rossano

Researchers are evaluating ALE.P03 monotherapy in adults with selected advanced or metastatic Claudin-1 positive CLDN1 solid tumors, including colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell carcinoma. The study includes Phase I dose escalation to determine the maximum tolerated dose and recommended dose for expansion, followed by Phase II to assess the recommended Phase II dose. The purpose is to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of ALE.P03. Participants will receive ALE.P03 through intravenous infusion. In Phase I dose escalation, the dose is gradually increased until the maximum tolerated dose or a safe recommended dose is identified. In Phase I dose expansion, patients receive the safe recommended dose to confirm the recommended Phase II dose. In Phase II, participants receive ALE.P03 at the recommended Phase II dose or according to the dosing schedule after the expansion phase. Throughout the study, patients will undergo assessments including monitoring for dose limiting toxicities, adverse events, overall and duration of response, disease control rate, and survival outcomes up to four years. Blood samples will be collected for detailed pharmacokinetic and antibody analyses from treatment initiation until the end of treatment. Safety follow-up occurs up to 30 days after the last dose, with long-term monitoring extending up to four years. The study evaluates both clinical outcomes and biological measures to understand the effects of ALE.P03.

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, randomized, open-label study aims to see if daraxonrasib can improve progression-free survival or overall survival in patients who have already received prior treatments. The study focuses on patients with locally advanced or metastatic NSCLC who cannot be cured with surgery or radiation. Participants will be randomly assigned in equal groups to receive either daraxonrasib tablets or docetaxel by intravenous infusion. The treatments will be given according to the study plan, and participants will be monitored over about four years. The study includes careful assessment of response to treatment, safety, quality of life, and drug characteristics during this period. During the trial, participants will undergo regular evaluations including imaging scans to measure tumor size, assessments of side effects, blood tests to check organ function, and questionnaires about quality of life. Researchers will track how long patients live without disease progression and overall survival, along with treatment effects and tolerability. This follow-up and monitoring will continue for up to approximately four years, ensuring comprehensive data collection throughout the study duration.