Study of ASN003 in Subjects With Advanced Solid Tumors

Exclusion Criteria

• •Have received prior chemotherapy, other investigational therapy, or major surgery within 4 weeks of Day 1;
• •Have received oral anti-cancer therapy with oral tyrosine kinase inhibitors within 14 days or 5 half-lives, whichever is longer.
• •Have received prior treatment with monoclonal antibodies within 6 weeks of first dose of Day 1;
• •Subject has received a live virus vaccine within the previous 8 weeks.
• •Have known central nervous system metastasis or primary tumor (Part A). Previously-treated, CNS metastasis is permitted in Part B. CNS metastasis must be small, discrete metastasis; stable for at least 30 days without the need for concomitant prednisone for symptom management. No leptomeningeal disease is allowed. Is receiving therapeutic doses of corticosteroids (\>20 mg prednisone daily or equivalent);
• •Has a serious concurrent medical condition such as:
• •* history of Diabetes Mellitus, type 1 or type 2,
• •* known autoimmune disease, known bleeding diathesis, history of congestive heart failure New York Heart Association (NYHA) class III or IV;
• •* uncontrolled hypertension (systolic BP ≥ 139 mmHg or diastolic BP ≥ 89 mmHg) at screening, despite optimal antihypertensive therapy,
• •* clinically significant heart disease including but not limited to: myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or known cardiac ejection fraction measurement of \< 50 %;
• •* history or family history of long QT syndrome; 12-Lead electrocardiogram (ECG) abnormalities considered by the investigator to be clinically significant or QTcF ≥ 450 milliseconds, regardless of clinical significance, at screening. Abnormal ECG may be confirmed with one repeat assessment. For subjects with QTcF ≥ 450 msec on initial ECG, the mean of the two QTcF assessments will determine eligibility;
• •* uncontrolled psychiatric illness;
• •* serious persistent infection within 14 days prior to the start of study medication;
• •* known gastrointestinal disease or condition which may affect the absorption of ASN003;
• •* known active or symptomatic viral hepatitis, chronic liver disease or liver cirrhosis;
• •* known glaucoma or other pre-existing ocular conditions that may put the patient at risk for ocular toxicities.
• •* any known condition or situation which may put the patient at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study
• •Female subjects who are pregnant or breast feeding