A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors

Inclusion Criteria

• Age 18 years or older;
• Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.
• Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1
• Eastern Cooperative Oncology Group performance score 0 to 2;

Exclusion Criteria

• Patients with symptomatic CNS metastases;
• Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV
• Any significant ophthalmologic abnormality
• Patients who have any severe and/or uncontrolled medical conditions
• Significant gastrointestinal abnormalities,
• Patients who have impaired cardiac function or clinically significant cardiac diseases,
• Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy;
• Treatment with third generation EGFR inhibitors
• Major surgery/surgical therapy for any cause within 4 weeks of Screening;