A Study of CS1001 in Combination With Regorafenib in Patients With Advanced or Refractory Solid Tumors

Exclusion Criteria

• •Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
• •Participants with any condition that impairs their ability to take oral medication, such as lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• •Has known central nervous system (CNS) metastases and/or carcinomatous meningitis that is either symptomatic or untreated.
• •Any prior (within 1 year) or current clinically significant ascites as measured by physical examination and that requires active paracentesis for control.
• •Significant history of cardiac disease within 6 months prior to Day 1 of Cycle 1, myocardial infarction within the previous year, or current cardiac ventricular arrhythmias requiring medication, or left ventricular ejection fraction (LVEF) is below 50%.
• •History or evidence of poorly controlled arterial hypertension.
• •Any serious or uncontrolled medical disorder or active infection may increase the risk associated with study participation or dose.
• •Administration of drugs known as strong CYP3A4 inducers or strong CYP3A4 inhibitors and the last dose was given in \< 5 half-lives from the first investigational product administration.
• •Any hemorrhage or bleeding event ≥ CTCAE Grade 3 within 28 days prior to the start of study treatment.