A Study of KF-0210 in Advanced Solid Tumors Patients

Inclusion Criteria:

1. Age ≥ 18 years old, male and female;

2. Patients are confirmed by available pathology records or current biopsy havingadvanced, nonresectable, or recurrent and progressing solid tumors since lastanti-tumor therapy, and who are unavailable or intolerable for available standardtherapy or there is no standard available therapy.

• Phase Ia (Dose Escalation): Advanced solid tumors;

• Phase Ib (Expansion Study): Patients must have any of the following tumor typeand have not participated in Phase Ia trial of this study: CRC (MSS), LC, SCCE,GC, and BC. Among them, patients with LC, SCCE, or GC must have undergonePD-1/PD-L1 treatment for at least 12 weeks and failed.

3. Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans orMRI no longer than 4 weeks before signing ICF);

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

5. Life expectancy≥ 3 months;

6. Females must not be lactating or pregnant at screening or baseline (negativepregnant test).

Exclusion Criteria:

1. Patients with prior anti-tumor therapy within 4 weeks prior to first dosing ofKF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);

2. Patients with prior definitive radiation therapy within 6 weeks prior to firstdosing of KF-0210, and the irradiated lesions showed no signs of progression if itto be considered target lesions. Or patients with prior palliative radiotherapywithin 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related sideeffects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;

3. Patients who have another active malignancy which is likely to require treatment;

4. Patients who have known active central nervous system (CNS) metastases and/orcarcinomatous meningitis;

5. Significant cardiovascular impairment: history of congestive heart failure greaterthan New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension,unstable angina, myocardial infarction, or stroke within 6 months prior to the firstdose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oralanticoagulation);

6. Patients with any active autoimmune disease or a documented history of autoimmunedisease, poorly controlled asthma or history of syndrome that required systemicsteroids or immunosuppressive medications, except for patients with vitiligo orresolved childhood asthma/atopy. Patients with asthma who require intermittent useof bronchodilators (such as albuterol) will not be excluded from this study;

7. Patients with inflammatory bowel disease or digestive tract diseases (e.g. pepticulcer disease, including stomach and duodenal ulcer, gastritis and enteritis);

8. Inability to take oral medication, or malabsorption syndrome or any otheruncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) thatmight impair the bioavailability of KF-0210;

9. Concurrent medical condition requiring the use of immunosuppressive medications, orimmunosuppressive doses of systemic or absorbable topical corticosteroids exceptinhaled or intranasal corticosteroids (with minimal systemic absorption);

10. Current use of NSAIDs, COX-1/COX-2 inhibitors within 4 weeks;

11. Patients who have received surgical or interventional treatment (excluding tumorbiopsy, puncture, etc.) within 28 days prior to first dosing of KF-0210;

12. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) prior to the first dosing of KF-0210;

13. Use of any live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oralpolio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 daysprior to the first dosing of KF-0210;

14. Any unresolved toxicities from prior therapy, greater than Common TerminologyCriteria for Adverse Events (CTCAE 5.0) grade 1 at the time of starting studytreatment with exception of alopecia;

15. Any uncontrolled or severe illness, including but not limited to: ongoing or activeinfection requiring parenteral antibiotics;

16. Positive screening tests for any one of them: human immunodeficiency virus (HIV)antibody, hepatitis B surface antigen (HBsAg); hepatitis B core antibody (HBcAb) (negative for HBsAg, but HBcAb positive, an HBV-DNA test will be performed and ifpositive will be excluded), hepatitis C antibody (anti-HCV positive, but negativeHCV RNA test is allowed to be included).