Oral STAT3 Inhibitor, TTI-101, in Patients With Advanced Cancers

All of the following inclusion criteria must be fulfilled for eligibility: 1. Age ≥18 years; 2. For patients with solid tumors (not unresectable HCC): Patients with histologically confirmed diagnosis of locally-advanced, inoperable, metastatic and/or treatment refractory solid tumors for whom there are no available therapies that will confer clinical benefit; 3. For patients with unresectable HCC: Patients with histologically confirmed diagnosis of locally advanced, inoperable, unresectable HCC who have failed first and second lines of therapy and Child-Pugh is A or beyond second line if the performance status is preserved and Child-Pugh is A. 4. Eastern Cooperative Oncology Group Performance status 0-1; 5. Hemoglobin ≥9.0 g/dL, neutrophil count ≥1.0 x 109/l, platelets ≥75 x 109/L; 6. Adequate renal function capability, as calculated by creatinine clearance \>40 ml/min using the Cockroft-Gault formula; 7. Adequate liver function defined as total bilirubin \<1.5 x ULN, and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \<3 x ULN. For subjects with liver involvement, AST/ALT \<5 x ULN; For subjects with liver involvement, AST/ALT \<5 x ULN; 8. Measurable disease using clinically appropriate criteria for the type of malignancy, RECIST v 1.1 for solid tumors; 9. Negative pregnancy test at the screening visit for women of childbearing potential, defined as: female subjects after puberty unless they have been postmenopausal for at least two years, are surgically sterile, or are sexually inactive and will remain so for the course of the trial; 10. Willingness to avoid pregnancy and breast feeding beginning two weeks before the first TTI-101 dose and ending three months after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must use adequate contraception in the judgment of the Investigator, such as a two-barrier method or a one-barrier method with spermicide or intrauterine device during trial treatment dosing and for 3 months after the last dose of the study; and 11. Ability to read and understand the informed consent form and willingness and ability to give informed consent and demonstrate comprehension of the trial before undergoing any trial activities.

Subjects are ineligible to enroll in this trial if they fulfill any of the following