MAX-10181 Given Orally to Patients With Advanced Solid Tumor

Inclusion Criteria:

• Males and/or females over age 18.
• Histologically or cytologically confirmed advanced or metastatic solid tumor for whichno established standard therapy is available.
• At least one measurable lesion by CT or MRI according to RECIST1.1, which is not inirradiated area (only for expansion phase).
• Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in caseof alopecia, Grade 2 is acceptable).
• Life expectancy of at least 3 months.
• Female participants of child bearing potential agree not to be pregnant or lactatingduring the study and for three months following the last dose of study drug. Both menand women of reproductive potential must agree to use a highly effective method ofbirth control during the study and for three months following the last dose of studydrug. A highly effective method of contraception is defined as one that results in alow failure rate, i.e., less than 1% per year, when used consistently and correctly.

Exclusion Criteria:

• Laboratory values not within the Protocol-defined range.
• Cardiac disease with New York Heart Association (NYHA) Class III or IV, includingcongestive heart failure, myocardial infarction within 6 months prior to the trialentry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
• Previously treated malignancies other than the current disease, except for adequatelytreated non-melanoma skin cancer, in situ cancer, or other cancer from which thesubject has been disease-free for at least 5 years at the trial entry.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemictherapy.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry,without complete recovery.
• Medical history of difficulty swallowing, malabsorption or other chronicgastrointestinal disease, or conditions that may hamper compliance and/or absorptionof the tested product.
• Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targetedtherapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
• Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleedingdiathesis.
• History of organ allograft, autologous stem cell transplantation, or allogeneic stemcell transplantation.
• Concomitant disease or condition that could interfere with the conduct of the trial,or that would, in the opinion of the Investigator, pose an unacceptable risk to thesubject in this trial.