A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration

This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.

Inclusion Criteria: 1. Participants should understand, sign, and date the written informed consent form prior to screening. 2. Male or female age 18 years or older 3. Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration 4. ECOG performance status 0 or 1 5. Life expectancy ≥ 3 months 6. Adequate organ function and bone marrow function 7. For participants participating exploration of food effect: 1)be able to eat a standardized high-fat, high caloric meal within 30 minutes. 2) be able to fast for 10 hours. Exclusion Criteria: 1. Known allergy or hypersensitivity to any component of the investigational product 2. Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS. 3. Has a known additional malignancy that is progressing or has required active treatment 4. Has swallowing dysfunction or malabsorption syndrome 5. Previous anti-tumor therapy, including chemotherapy ,endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life ,radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment. 6. Major surgery within 4 weeks of the first dose of investigational product or with any unhealed surgical wounds, infection or dehiscence. 7. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity; 8. Participants use proton pump inhibitors for at least 7 days prior to the first dose of ABSK211 and during treatment with ABSK211. 9. P-gp inhibitor, moderate and strong CYP3A inhibitors to 7 days or 5 half-lives and for strong CYP3A inducers to 2 weeks or 5 half-lives ; 10. Active central nervous system (CNS) metastases; 11. History of interstitial lung disease (ILD) requiring systemic steroid treatment; 12. Heart disease or medical history ; 13. NSCLC cohorts: Participant previously identified as having a driver mutation and have not received any targeted therapy; 14. Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody; 15. Exclusion of hepatitis infection; 16. Participants with refractory/uncontrolled ascites or pleural effusion; 17. Pregnant or nursing (lactating) women; 18. Partners of non-surgically sterilized male participants or female participants of childbearing potential who refuse to use effective methods of birth control during the study and for up to 6 months after the last dose of investigational product; 19. Sexually active males who refuse to use a condom during medication period and until 3 months after stopping investigational product; 20. Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines ; 21. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition; \-