CTS2190 Phase I /II Clinical Study in Patients

Inclusion Criteria:

Subjects who meet all of the following criteria can be included in this study:

1. Male or female ≥ 18 years of age at signing of ICF.

2. Part 1: histologically or cytologically confirmed locally advanced or metastaticsolid tumors at screening who cannot be treated surgically and have failed standardtreatment (PD during treatment or after the last treatment) recommended by thecurrent clinical diagnosis and treatment standards or guidelines, or cannot toleratestandard treatment, or refuse standard treatment and/or currently have no effectivetreatment available. Part 2: histologically or cytologically confirmed advanced solid tumors (includingpancreatic cancer, non-small cell lung cancer and/or other tumors, such as gastriccancer, colorectal cancer, etc.) at screening who cannot be treated surgically andhave failed standard treatment (PD during treatment or after the last treatment)recommended by the current clinical diagnosis and treatment standards or guidelines,or cannot tolerate standard treatment, or refuse standard treatment and/or currentlyhave no effective standard treatment available.

3. At least one measurable tumor lesion at screening [according to RECIST V1.1 criteria (see appendix 1)].

4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Appendix 2) atscreening.

5. With a life expectancy ≥ 12 weeks at screening.

6. With good organ function at screening, including:

• Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (ifthe following conditions occur, isolated bilirubin >1.5 × ULN is acceptable if:bilirubin is fractionated and direct bilirubin <35%, or the patients isdiagnosed with Gilbert syndrome), alanine aminotransferase (ALT) ≤ 2.5 × ULN,and aspartate aminotransferase (AST) ≤ 2.5 × ULN (for patients with livermetastases or tumor infiltration, the criteria can be relaxed to TBIL ≤ 1.5 ×ULN, ALT ≤5 × ULN, and AST ≤ 5 × ULN);

• Renal function: blood creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50mL/min [calculate the creatinine clearance using Cockcroft-Gault formula (appendix 3)];

• Hematology: platelet ≥ the lower limit of the laboratory normal range, andabsolute neutrophil count (ANC) ≥ 1.5 × 109/L, and hemoglobin ≥ 100 g/dL;

• Cardiac function: QT interval corrected by Fridericia method (QTcF) ≤ 450 ms (male) or ≤ 470 ms (female) (see the appendix 3 for calculation formula).

• Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, oractivated partial thromboplastin time (APTT) ≤ 1.5 × ULN.

7. Female patients of non-childbearing age or female patients of childbearing age whohave negative pregnancy test results and promise to take sufficient and effectivecontraceptive measures or adhere to abstinence from the screening period to 90 daysafter the last administration, or male patients who promise to take sufficient andeffective contraceptive measures or adhere to abstinence from the screening periodto 90 days after the last administration (see the appendix 4). Patients are notallowed to donate sperm within 6 months from the start of administration to 6 monthsafter the end of investigational drug administration.

8. Patients who understand and voluntarily signs the ICF, are willing to and able tocomplete the scheduled visits, treatment plan, laboratory tests and other studyprocedures.

Exclusion Criteria:

Subjects should not participate in this clinical study if any of the following conditions is met:

1. Female patients in pregnancy or lactation.

2. Patients with dysphagia.

3. Patients who cannot tolerate venipuncture or have a history of syncope judged by theinvestigator to be clinically significant.

4. Uncontrolled tumor-related pain.

5. Allergic or intolerant to the active ingredients or excipients of theinvestigational drug judged by the investigator.

6. Treatment with radiotherapy for the target lesion within 4 weeks before the firstadministration of the investigational drug, or accepted any anti-tumor drugs/treatments (including but not limited to chemotherapy, targeted therapy,immunotherapy) within 5 half-lives before the first administration of theinvestigational drug, whichever is longer; or patients who have received herbaltherapies with anti-tumor indications within 1 week before the first administration.

7. Primary central nervous system (CNS) tumor or CNS metastasis at screening. Thefollowing patients can be considered for enrollment: after treatment and beingstable for ≥ 3 months, patients who have completed the treatment at least 10 daysbefore the start of the study treatment; the corticosteroid treatment has beenterminated for ≥ 5 days when the study treatment starts, the neurological functionis stable, and it is estimated that no steroids or antiepileptic drugs will berequired during the study treatment.

8. Patients judged by the investigator to have uncontrolled pleural effusion,pericardial effusion, or peritoneal effusion (requiring repeated drainage, multipletimes a month or more frequently) at screening. Allow patients to indwell cathetersregardless of drainage frequency.

9. Patients with untreated or clinically symptomatic spinal cord compression that hasnot been controlled (except for patients who have received treatment and have stablesymptoms, whose imaging examination shows that they are stable for at least 4 weeksbefore the first administration, and who have no evidence of brain edema and do notrequire glucocorticoid treatment).

10. Patients with ≥ 2 malignant tumors within 5 years before the first administration.Except for cured early-stage malignancies (carcinoma in situ or stage I tumor), suchas adequately treated cervical carcinoma in situ, basal cell or squamous epithelialcell skin cancer.

11. Patients who are found to have active pulmonary tuberculosis infection within 1 yearbefore enrollment through medical history, or those with a history of activepulmonary tuberculosis infection more than one year ago who have not received formaltreatment.

12. Interstitial lung disease or interstitial pneumonia, including clinicallysignificant radiation pneumonia (i.e., affecting activities of daily living orrequiring intervention).

13. Severe infection within 4 weeks before the first administration, including but notlimited to bacteremia and severe pneumonia, etc. requiring hospitalization; CTCAE ≥grade 2 active infection requiring systemic antibiotic treatment within 2 weeksbefore the first administration.

14. History of serious cardiovascular and cerebrovascular diseases, including but notlimited to serious cardiac rhythm or conduction abnormalities, such as ventriculararrhythmia requiring clinical intervention, degree II-III atrioventricular block,etc.; acute coronary syndrome, congestive cardiac failure, aortic dissection, strokeor other grade 3 or above cardiovascular and cerebrovascular events within 6 monthsbefore the first administration; New York Heart Association (NYHA) cardiac functionclassification (see appendix 5) ≥ grade II or left ventricular ejection fraction (LVEF)<50% or hypertension that cannot be clinically controlled (systolic bloodpressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).

15. Positive hepatitis B virus surface antigen (HBsAg) and the number of copies ofhepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500 copies, orthe lower limit of the positive detection value of the study site) at screening,HBsAg (-), hepatitis B core antibody (HBcAb) (+) and the number of copies of HBVDNA≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection valueof the study site) after treatment of HBV infection, or positive hepatitis Cantibody (HCVAb) and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ ULN of thestudy site; those with a history of liver cirrhosis (Child Pugh class B or C) oractive syphilis infection.

16. Patients who have active diseases or a history of autoimmune diseases that mayrelapse (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis,etc.) at screening, except patients suffering clinically stable autoimmune thyroiddisorder.

17. History of immunodeficiency, including HIV positive, or those suffering from otheracquired or congenital immunodeficiency diseases, or with a history of allograft.Autotransplantation should be completed at least 3 months before screening.

18. Those who had clinically significant hemorrhage symptoms within 3 months before thefirst administration. Patients who significantly coughed up blood within 4 weeksbefore the first administration of the investigational drug, and the amount ofhemoptysis each time reached half a teaspoon (2.5 mL) or more; patients who hadarterial/venous thrombosis events within 6 months before the first administration,such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism,central retinal vein occlusion (RVO), etc.; those who are receiving anticoagulanttreatment at the time of screening; patients with potential thrombosis or at therisk of coagulation judged by the investigator.

19. Patients who have received other unlisted clinical investigational drugs ortreatments within 4 weeks (or 5 drug half-lives, whichever is longer) before thefirst administration.

20. Patients who have used live vaccine or attenuated vaccine within 4 weeks before thefirst administration, or plan to use live vaccine or attenuated vaccine during thestudy period.

21. Patients who have used potent cytochrome enzyme (CYP)3A4 inhibitors or inducerswithin 2 weeks before the first administration, or need to use potent CYP3A4inhibitors or inducers until 7 days after the last dose (see the appendix 6).

22. Major surgery (except for surgery for diagnostic purposes) within 4 weeks before thefirst administration, or expected to undergo major surgery (except for surgery fordiagnostic purposes) during the study period, or have undergone diagnostic orminimally invasive surgery within 7 days before the first administration.

23. Adverse reactions from previous anti-tumor treatment have not recovered to ≤ CTCAEV5.0 grade 1 (except for alopecia and grade 2 neurotoxicity caused by chemotherapydrugs, grade 2 hypothyroidism caused by anti-tumor treatments, hypertension andother toxicities that are judged to have no safety risks by the investigator).

24. Patients who are judged by the investigator to have a history of other serioussystemic diseases, or not suitable for participating in the trial for any otherreason (the patient has mental illness, alcohol abuse, drug use or drug abuse thatmay affect his/her compliance with the trial or may interfere with theinterpretation of the study results).