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

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;

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