First-in-human Study of Oral TP-0184 in Patients With Advanced Solid Tumors

Exclusion Criteria

• •1. History of congestive heart failure (CHF); cardiac disease, myocardial infarction within the past 6 months prior to Cycle 1 Day 1; left ventricular ejection fraction (LVEF) \<45% by echocardiogram (ECHO), unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG) within 14 days prior to Cycle 1 Day 1
• •2. Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>450 msec in men and \>470 msec in women
• •3. Have a seizure disorder requiring anticonvulsant therapy
• •4. Presence of symptomatic central nervous system metastatic disease or disease that requires local therapy such as radiotherapy, surgery, or increasing dose of steroids within the prior 2 weeks
• •5. Have severe chronic obstructive pulmonary disease with hypoxemia (defined as resting O2 saturation of ≤90% breathing room air)
• •6. Have undergone major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1
• •7. Have active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• •8. Are pregnant or nursing
• •9. Received treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within 28 days or 5 half lives, whichever occurs first, prior to study entry (6 weeks for nitrosoureas or Mitomycin C)
• •10. Are unwilling or unable to comply with procedures required in this protocol
• •11. Have known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Patients with history of chronic hepatitis that is currently not active are eligible.
• •12. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
• •13. Are currently receiving any other investigational agent
• •14. Have exhibited allergic reactions to a similar structural compound, biological agent, or formulation
• •15. Have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption
• •16. Have hemochromatosis or a transferrin saturation (TS) \>50% in men or \>45% in women at baseline or noted during the study via scheduled iron panel monitoring