Overview

This is a phase 1 study of the combination of cedazuridine with decitabine in patients with solid tumors. At least 6 patients will be enrolled per treatment level to assess optimal hypomethylation and toxicity (up to 35 patients total).

Eligibility

Inclusion Criteria:

• Participants must have advanced, unresectable, and/or metastatic solid tumor malignancy that is histologically or cytologically confirmed.
• Patients must have received at least 2 lines of therapy in the advanced/metastatic setting (if 2 lines exist) and have no other possible therapies or refuse therapies that have shown clinical benefit for their condition.
• ECOG performance status <1
• Ability to understand and the willingness to sign a written informed consent document.
• Patients must have measurable disease
• Ability to swallow oral medications

Exclusion Criteria:

• Participants who have had chemotherapy or radiotherapy within 3 weeks
• Participants may not be receiving any other investigational agents.
• Active hepatitis B or hepatitis C infection.
• Active or untreated gastric or duodenal ulcer
• Symptomatic bowel obstruction within 3 months prior to screening visit.
• Symptomatic ascites in the last 4 weeks

Other protocol defined inclusion/exclusion criteria may apply.