Phase 12 Study of ODM-212 Tablets for Treatment of Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating ODM-212, a drug being studied in a first-in-human, multi-site, open-label Phase 12 clinical trial involving adults with selected advanced solid tumors that cannot be treated with curative intent. The study aims to assess the safety and side effects of ODM-212 in patients who have cancers such as mesothelioma, lung carcinoma, colorectal cancer, and others with specific genetic alterations. This research is sponsored by Orion Corporation, Orion Pharma. Participants receive ODM-212 tablets at doses of 5mg andor 40mg. The study has two parts an initial dose escalation phase to find a safe dose, followed by a dose expansion phase that includes patients with solid tumors harboring specific genetic pathway alterations. Treatments are given orally, and dosing details are adjusted based on patient response and safety observations. During the study, participants will be monitored from the first dose until one year after the last study visit to track treatment-emergent adverse events and their severity. Regular assessments include physical exams, laboratory tests, and performance status evaluations. Participants must comply with the protocol and provide informed consent. The total study duration varies based on treatment and follow-up schedules.

A Phase 1/2, First-in-Human Study On ODM-212 In Subjects With Selected Advanced Solid Tumours