A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of TT125-802 in Subjects With Advanced Solid Tumors

Inclusion Criteria:

• Males and nonpregnant and non-breastfeeding females, aged ≥ 18 years of age at thetime of signing the informed consent.

• Subjects with advanced solid tumors resistant or refractory to standard treatment.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Measurable disease per RECIST 1.1 criteria.

• Adequate hematological function defined by absolute neutrophil count, ≥ 1.5 × 10^9/L, platelet count ≥ 100 × 10^9/L, and hemoglobin ≥ 9 g/dL, and without growthfactor treatment or blood transfusion within 2 weeks before the study interventionstart.

• Adequate hepatic function defined by total bilirubin level ≤ 1.5 × upper limit ofnormal (ULN), aspartate aminotransferase (AST) level ≤ 3 × ULN, and an alanineaminotransferase (ALT) level ≤ 3 × ULN.

• Adequate renal function defined by creatinine clearance > 60 mL/min according to theCockcroft-Gault equation or creatinine levels <1.5 mg/dl.

• Adequate coagulation laboratory assessments, as follows: Prothrombin time (PT) orpartial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), orinternational normalized ratio (INR) < 1.5 or within target range if on prophylacticanticoagulation therapy.

• Life expectancy of > 3 months, in the opinion of the Investigator.

• Willing to adhere to contraception, egg and sperm donation, the fasting requirement,and other criteria as described in lifestyle restrictions

• Capable of giving signed informed consent.

Exclusion Criteria:

• Clinically significant (i.e., active) uncontrolled intercurrent illness.

• Presence of brain metastases unless clinically stable.

• History or presence of malignancies unless curatively treated with no evidence ofdisease ≥ 2 years.

• Subjects with known human immunodeficiency virus and/or active viral hepatitis (Band/or C), and subjects on viral hepatitis B therapy are excluded. However, subjectswith hepatitis C treated with curative therapy are not considered actively infected.

• Subject received a live vaccine within 30 days prior to the first dose of the studytreatment administration.

• Serious gastrointestinal bleeding within 3 months, refractory nausea and vomiting,uncontrolled diarrhea, known malabsorption, significant small bowel resection orgastric bypass surgery, use of feeding tubes, other chronic gastrointestinaldisease, and/or other situation that may preclude adequate absorption of oralmedications.

• Subjects that have received a strong CYP3A4 inhibitor within 7 days prior to thefirst dose of TT125-802 or a strong CYP3A4 inducer within 14 days prior to the firstdose of TT125-802.

• Hypersensitivity to the active substance or to any of the excipients of TT125-802.