The purpose of this study is to determine the safest, most effective dose of an investigational drug called INCA32459 for individuals with certain advanced cancers (malignancies). The study also aims to understand how INCA32459 affects the body, as well as determine its preliminary efficacy (how it works against cancer) in these patients. The study has 2 parts. In Part 1, researchers will evaluate the safety and effects of INCA32459 at different doses. The study will also examine the highest dose of INCA32459 that people can take with the fewest side effects (“dose escalation”). Part 2 will begin after the safest dose/s of INCA32459 have been chosen in Part 1 and will only enroll individuals with melanoma or a certain type of head and neck cancer (“squamous cell”) that expresses a protein called PD-L1. In Part 2, researchers will further examine the safety of INCA32459 at the chosen doses and the effects it may have on the patient’s cancer, if any (“dose expansion”).
What is the full name of this clinical trial?
INCA32459: A Phase 1, Open-Label, Multicenter Study of INCA32459 in Participants With Select Advanced Malignancies