Study of TT-00420 (Tinengotinib) Tablet as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

Inclusion Criteria:

1. ≥ 18 years of age
2. Histopathological or cytologically documented locally advanced or metastatic solidtumors who have no available standard therapeutic treatment options
3. At least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Adequate organ function confirmed at screening and within 10 days of initiatingtreatment, as evidenced by:

• Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
• Hemoglobin (Hgb) ≥ 8 g/dl
• Platelets (plt) ≥ 75 x 10^9/L
• AST/SGOT and ALT/SGPT ≤ 2.5 x Upper Limit of Normal (ULN) or ≤ 5.0 x ULN if livermetastases are present
• Total bilirubin ≤ 1.5 x ULN
• Calculated creatinine clearance ≥ 50 mL/min (Cockcroft Gault formula)

6. Negative pregnancy test within 72 hours before starting study treatment in allpremenopausal women and women < 12 months after the onset of menopause
7. Must agree to take sufficient contraceptive methods to avoid pregnancy during thestudy and until at least 6 months after ceasing study treatment
8. Able to sign informed consent and comply with the protocol

Exclusion Criteria:

1. Women who are pregnant or lactating
2. Women of child-bearing potential (WOCBP) who do not use adequate birth control
3. Patients with any hematologic malignancy, including leukemia (any form), lymphoma, andmultiple myeloma
4. Patients with a history of primary central nervous system tumors or carcinomatousmeningitis.
5. Patients with the following mood disorders as judged by the Investigator or apsychiatrist:

• Medically documented history of or active major depressive episode, bipolardisorder (I or II), obsessive-compulsive disorder, schizophrenia; a history ofsuicidal attempt or ideation, or homicidal ideation (immediate risk of doing harmto others)
• ≥ CTCAE grade 3 anxiety

6. Impaired cardiac function or significant diseases, including but not limited to any ofthe following:

• left ventricular ejection fraction (LVEF) < 45% as determined by multigatedacquisition (MUGA) scan or echocardiogram (ECHO)
• Congenital long QT syndrome
• QTcF ≥ 480 msec on screening ECG
• Unstable angina pectoris ≤ 3 months prior to starting study drug
• Acute myocardial infarction ≤ 3 months prior to starting study drug

7. Patients with:

• unresolved diarrhea ≥ CTCAE grade 2, or
• impairment of gastrointestinal (GI) function, or
• GI disease that may significantly alter the absorption of TT-00420

8. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g.,uncontrolled hypertension, uncontrolled hypertriglyceridemia, or active oruncontrolled infection) that could cause unacceptable safety risks or compromisecompliance with the protocol
9. Patients who have received chemotherapy, targeted therapy, or immunotherapy ≤ 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to starting study drug or who have notrecovered from side effects of such therapy
10. Patients who have received wide field radiotherapy ≤ 4 weeks or limited fieldradiation for palliation ≤ 2 weeks prior to starting study drug or who have notrecovered from side effects of such therapy
11. Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug orwho have not recovered from side effects of such therapy
12. Patients who have been treated with any hematopoietic colony-stimulating growthfactors (e.g., G-CSF, GM-CSF) ≤ 4 weeks prior to starting study drug.
13. Patients who are currently receiving treatment with therapeutic doses of warfarinsodium or any other coumarin-derivative anticoagulants
14. Patients who have received systemic corticosteroids ≤ 2 weeks prior to starting studydrug or who have not recovered from the side effects of such treatment.
15. Patients who are currently receiving treatment with strong CYP3A inhibitors orinducers ≤ 2 weeks prior to starting study drug.
16. Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is notmandatory; patients with well controlled HIV might be enrolled)
17. Known history of active infection with Hepatitis B or Hepatitis C
18. Has received a live-virus vaccination within 30 days of planned first dose
19. Inability to swallow or tolerate oral medication
20. Has a history or current evidence of any condition, therapy, or laboratory abnormalitythat, in the opinion of the investigator, might confound the results of the trial,interfere with the patient's safe participation and compliance in the trial.