Phase 12 Open-label Study of ODM-212 Combined With Anti-cancer Therapies in Adults With Advanced Solid Tumors Including Mesothelioma, Pancreatic Cancer, and NSCLC

What this Trial Is About

Researchers are conducting an open-label, multi-site, multi-cohort phase 12 trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 combined with anti-cancer therapies in participants with advanced solid tumors, including mesothelioma, pancreatic cancer, and advanced non-small cell lung cancer NSCLC. The study aims to understand how ODM-212 works alongside other treatments in these serious cancers. The trial has two parts dose escalation and dose expansionoptimization. Participants receive ODM-212 tablets along with other anti-cancer drugs depending on their cancer type. For mesothelioma, ODM-212 is combined with ipilimumab and nivolumab given intravenously on specific schedules. For pancreatic cancer, it is combined with gemcitabine and nab-paclitaxel administered intravenously in cycles. For NSCLC with a KRAS G12C mutation, ODM-212 is combined with sotorasib taken orally daily in 21-day cycles. Participants will be closely monitored throughout the study, with evaluations of side effects, dose-limiting toxicities, and adverse events tracked on average for two years. The research team will collect tumor tissue samples, monitor treatment adherence, and perform assessments to measure disease status and treatment effects. Safety will be carefully checked with exams, ECGs, and laboratory tests. The study is planned to continue through 2029, with ongoing visits and follow-ups as part of participant involvement.

A 2-part Phase 1/2 Open-label Trial on ODM-212