Study of TP-3654 in Patients With Advanced Solid Tumors

Inclusion Criteria

• •1\. Have a histologically confirmed diagnosis of advanced metastatic, progressive or unresectable solid tumor
• •2\. Be refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition.
• •3\. Have 1 or more tumors measurable or evaluable as outlined by modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• •4\. Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2
• •5\. Have a life expectancy greater than or equal to 3 months
• •6\. Be greater than or equal to 18 years of age
• •7\. Have a negative pregnancy test (if female of childbearing potential) and not currently nursing
• •8\. Have acceptable liver function:
• •a. Bilirubin less than or equal to 1.5x upper limit of normal (ULN) (unless associated with Gilbert's syndrome b. Aspartate aminotransferase (AST/SGOT), alanine aminotransferase (ALT/SGPT) and alkaline phosphatase less than or equal to 2.5x upper limit of normal (ULN) \*If liver metastases are present, then less than or equal to 5x ULN is allowed.
• •9\. Have acceptable renal function:
• •a. Calculated creatinine clearance greater than or equal to 30 mL/min
• •10\. Have acceptable hematologic status:
• •a. Absolute Neutrophil Count (ANC) greater than or equal to 1500 x10\^9/L b. Platelet count greater than or equal to 100,000 x 10\^9/L c. Hemoglobin greater than or equal to 8 g/dL
• •11\. Have acceptable coagulation status:
• •1. Prothrombin time (PT) within 1.5 x normal limits
• •2. Activated partial thromboplastin time (aPTT) within 1.5 x normal limits
• •12\. Be nonfertile or agree to use an adequate method of contraception. Sexually active patients and their partners must use an effective method of contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and for the duration of study participation and for 3 months (males) and 6 months (females) after the last study drug dose. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• •13\. Have read and signed the Institutional Review Board (IRB)-approved informed consent form prior to any study related procedure. (In the event that the patient is re-screened for study participation or a protocol amendment alters the care of an ongoing patient, a new informed consent form must be signed.)