We are doing this study to find out if an experimental drug called BBI-355 (the study drug) is a safe and effective option for people with solid tumor forms of cancer. We also want to know the best dosing strategy for the drug. We plan to have later parts of this study that will look at how the study drug works when it is given with other cancer drugs.

Solid Tumors

Adults ages 18+ who:

• Are diagnosed with a solid tumor form of cancer
• Have locally advanced or non-resectable (cannot be removed by surgery) disease

For more information about who can join this study, please contact the study team at hollie.watson@duke.edu.

If you choose to join the study and are found to be eligible for dosing, you will take the study drug for a series of 28-day periods called "cycles." There are 5 possible dosing schedules to which you will be assigned. Your possible assignments will be:

• 1) Every other day: dosing of the study drug on days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, and 27 of each 28-day cycle
• 2) 2 days on/5 days off: daily doses of the study drug for 2 days in a row followed by 5 days of no dosing, which is repeated weekly during each cycle
• 3) Days 1 and 3 dosing: once daily dosing of the study drug on days 1 and 3 each week, which is repeated weekly during each cycle
• 4) 3 days on/11 days off: daily doses of the study drug for three days in a row followed by eleven days of no dosing, which is repeated weekly during each cycle
• 5) Once per week: 1 dose of the study drug per week

The study drug is a table that you take by mouth.