An Investigation of TAS-119 Monotherapy

Inclusion Criteria

• •1. Is a male or female, ≥ 18 years of age, who has provided written informed consent.
• •2. Has histologically or cytologically confirmed advanced, unresectable, metastatic solid tumor(s) for which the patients have no available therapy likely to provide clinical benefit.
• •3. Must have an archival FFPE tumor sample available, to be provided to the Sponsor upon request.
• •4. In the Expansion Phase: patients should be willing to undergo tumor core biopsy procedure at pre-treatment and on Day 4, Cycle 1 if, in the judgment of the investigator, it is considered clinically safe and appropriate to do so. This requirement is optional but preferred for patients in Dose Escalation.
• •5. Has adequate organ function.
• •Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to starting the study drug. Both males and females and must agree to use effective birth control during the study if conception is possible during this interval.
• •Exclusion:
• •1. Has received prior treatment with TAS-119.
• •2. Has received treatment with any proscribed treatments within specified time frames prior to study drug administration.
• •3. Has a serious illness or medical condition(s).