If you are eligible to participate in this study, you will undergo one or more of the study procedures at each study visit. Some of these procedures may no longer be necessary depending on the visit day in the study treatment cycle. Your study doctor will let you know if you are not required to undergo a procedure. Please note that you may be asked to repeat a procedure or test and/or have additional procedures if your study doctor feels it is needed to evaluate your condition. Your study doctor may ask you to come in early for some procedures because of scheduling. If not indicated otherwise the listed procedures would be applicable for both stages of the study (Stage 1 and Stage 2) ● Medical/ Cancer/ Surgical history: On Cycle 1 Day 1, any additional medical history observed after signing of the informed consent form but before the first dose of the study drug and not considered related to study-required procedures will be recorded in the medical history. ● Vital Signs (blood pressure, heart rate, respiratory rate, oxygen saturation (SpO2) and body temperature), weight ● You will be asked about: - Any changes to the medications you are taking - Any side effects that you are experiencing, which may or may not be related to the study - If you have made any visits to other doctors or hospitals You will receive an Adverse Event (side effect) and Prior/Concomitant therapy dispensation log and instructions on how to complete it. ● Biomarker and/or exploratory research - Blood/Plasma to help understand the effects or