Summary
This study is recruiting people with locally advanced or metastatic solid tumours who have failed at least one standard of care therapy, or were intolerant to a standard of care therapy, or have refused such treatment.
The study will firstly enroll participants into a dose escalation study. Participants who choose to enrol in the escalation study will be assigned a specific number of tablets of RX108-A to take each day for 3 weeks, followed by a 1 week rest. Participants will be asked to keep a diary of any side effects that they experience while taking the experimental treatment, and may be asked to stop taking the tablets if they experience any severe side effects. Participants will also be asked to provide blood samples at 4 different times during their 3-week treatment cycle. New groups of participants will be enrolled to test each higher dose of the experimental treatment until the best tolerated dose is identified.
After the best tolerated dose has been identified, a new group of up to 9 participants will be enrolled for the dose expansion study. Participants who choose to enroll in the expansion study will be assigned a specific number of tablets to take each day for 3 weeks, followed by a 1 week rest. Participants in this study will be asked to keep taking the tablets for 3-week cycles for up to 7 months, and will be asked to provide blood samples at different timepoints during their first 3-week treatment cycles.
It is hoped this research will determine the highest safe dose of RX108-A that reduces the growth of tumours in people with locally advanced or metastatic solid cancers.