Study of CP-383 for Patients with Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Have cancer that can be measured or assessed for changes.
• Cannot take or are not eligible for standard cancer treatments.
• Have a tumor sample available for testing or are willing to have a biopsy.
• Diagnosed with advanced, recurrent, or metastatic cancer that cannot be cured.
• For Part 1: Have any solid tumor (except brain cancer) that has progressed, where standard treatment is no longer effective or too toxic, and a clinical trial is an option.
• For Part 1: Have specific advanced, metastatic cancers like colorectal, small cell lung, head and neck, non-small cell lung, pancreatic, or bladder cancer, some with specific gene mutations.
• For Part 2: Have specific advanced, metastatic cancers like colorectal, small cell lung, or head and neck cancer, some with specific gene mutations.
• Have adequate blood and urine test results.
• Use effective contraception if of childbearing potential.
• Provide written informed consent.
• Willing to follow the study requirements.

Exclusion Criteria

• Cannot swallow pills.
• Have a history of HIV, HCV, or HBV unless controlled with undetectable viral load.
• Have an active brain tumor.
• Have significant liver disease.
• Have serious gastrointestinal diseases.
• Have had another cancer in the past 5 years, with some exceptions for likely cured cancers.
• Have significant heart disease.
• Have other uncontrolled diseases that could make taking the drug unsafe.
• Are pregnant or breastfeeding.
• Have taken certain anti-cancer or other drugs recently before starting the study drug.