The purpose of this study is to determine the appropriate dosage, safety and effectiveness of a new study drug IPN01195 in adults with advanced solid tumours.
The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body.
Participants must be ≥18 years of age or the country's legal age of majority if the legal age is more than 18 years at the time of signing the informed consent.
Participants with histologically confirmed metastatic solid tumour for whom no suitable alternative standard therapy exists.
Participants must bear tumours harbouring selected classes of genetic alterations of MAPK pathway based on an analytically validated assay performed by an accredited laboratory.
Part A: Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, for central confirmation of mutation status.
Gastrointestinal conditions that could impair absorption of IPN01195 (specific cases e.g. remote history of gastrointestinal surgery, may be enrolled after discussion with the medical monitor)
Any evidence of severe active infection or inflammatory condition.
Non-adequate cardiac function
Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant's ability to cooperate with the requirements of the study.
Sequential
IPN01195
DrugIPN01195 will be administered at assigned dose level.
Part A: Percentage of participants with dose limiting toxicity (DLT)
Part A and B: Percentage of participants experiencing treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TE SAEs).
An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE is an AE for which the start date is on or after the date that the intervention began.
Part A and B: Percentage of participants with dose interruptions and permanent treatment discontinuations
Part B: Objective response rate (ORR)
Objective response rate is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator per RECIST version 1.1.
Part A: Time to maximum observed drug concentration (Tmax) after single and multiple doses of IPN01195
Part A: Maximum observed drug concentration (Cmax) after single and multiple doses of IPN01195
Part A: Area under the plasma concentration time curve (AUCtau) after single and multiple doses of IPN01195
AUCtau is defined as the concentration of drug over one dosing interval.
Part A: Geometric mean ratio of Cmax of IPN01195 administered in fed state relative to fasted state.
