A Dose-Escalation Study of Onc201 Administered Every One or Three Weeks in Advanced Solid Tumors and Multiple Myeloma

Inclusion Criteria

• •1. Solid tumor specific:
• •* Patients must have a histologically/cytologically confirmed primary solid tumor
• •* Radiographic or clinical evidence of advanced/metastatic malignant disease that is resistant to standard therapy or for which no standard therapy is available. Lesions may be measurable or non-measurable
• •2. Multiple myeloma specific:
• •* Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment
• •* Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present), (\>=0.2 g excreted in a 24 hour collection sample).
• •* Subjects with free light chain only disease are excluded
• •3. All previous therapies for cancer, including radiotherapy, major surgery and investigational therapies discontinued for ≥ 14 days (≥ 28 days for mitomycin C or nitrosoureas ) before Cycle 1 Day 1 (C1D1), and all acute effects of any prior therapy resolved to baseline severity or Grade ≤ 1 Common Terminology Criteria for Adverse Events (CTCAE v4.03), except alopecia or parameters defined in this eligibility list
• •4. Age ≥ 18 years
• •5. ECOG performance status ≤ 1
• •6. Adequate organ and marrow function as defined below:
• •* Absolute neutrophil count ≥1,000/mm3 without growth factor use ≤ 7 days prior to C1D1
• •* Platelets ≥75,000/mm3 without platelet transfusion ≤ 7 days prior to C1D1
• •* Hemoglobin \>8.0 mg/dL without red blood cell transfusion ≤ 7 days prior to C1D1
• •* Total serum bilirubin \<1.5 X upper limit of normal (ULN)
• •* AST (SGOT)/ALT (SGPT) ≤2 X ULN; ≤ 5 X ULN if there is liver involvement secondary to tumor
• •* Serum creatinine ≤ 1.5 X ULN (OR creatinine clearance ≥ 60 mL/min/1.73 m2)
• •* Serum or urine pregnancy test (for females of childbearing potential) negative ≤7 days of starting treatment
• •7. Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
• •8. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate.