A Study of APX3330 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. Diagnosed with another malignancy within the past 2 years (excluding a history of carcinoma in situ of the cervix, superficial non-melanoma skin cancer, superficial bladder cancer, or endometrial cancer that has been adequately treated, or stage 1 prostate cancer that does not require treatment).
• •2. History of a major surgical procedure or a significant traumatic injury within 14 days prior to commencing treatment, or the anticipation of the need for a major surgical procedure during the course of the study.
• •3. Patients who have been treated with an investigational agent within 21 days prior to the first dose of study drug.
• •4. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association (NYHA) class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B, C or HIV, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.
• •5. Impaired liver function Child-Pugh class B or C (score 7-15).
• •6. Women who are pregnant or lactating.
• •7. Patients with evidence of symptomatic brain metastases. Patients with treated (surgically excised or irradiated) and stable brain metastases are eligible assuming the patient has adequately recovered from treatment, the treatment was at least 28 days prior to initiation of study drug, and baseline brain computed tomography (CT) with contrast, or magnetic resonance imaging (MRI) within 14 days of initiation of study drug, is negative for new or worsening brain metastases
• •8. Other concurrent chemotherapy, immunotherapy, radiotherapy or investigational therapy except for hormonal therapy (e.g., tamoxifen, etc.).
• •9. Patients requiring palliative radiotherapy to lesions that are defined as target lesions by RECIST criteria at the time of study entry.