A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-011 in Patients With Advanced Solid Tumor

Inclusion Criteria:

1. Male or female, age 18 ~ 75 (include both ends, or other age range required by localregulations or IRB).

2. Escalation Part: Patients must have histological or cytological confirmed advancedsolid tumors that have progressed on or intolerant to standard therapy or whom nostandard therapy exists; and patients with advanced HCC must satisfy:

3. BCLC stage B or C and Child-Pugh score 5~6

4. Patient must provide archived tissue sample or biopsy for FGF19 overexpressioncentral lab testing Expansion Part: patients must have histological or cytological confirmed, BCLC stageB or C HCC, and have progressed on or intolerant to or have refused to receive orhave no access to receive first line systemic therapy (by localguideline/regulation) and is unsuitable for other standard therapy(ies) (by localguideline/regulation) against HCC, and must satisfy:

5. Patient must provide archived tissue sample or biopsy for FGF19 overexpressioncentral lab testing, and the result must be positive

6. Patient must have at least 1 measurable lesion (RECIST V1.1)

7. Child-Pugh score 5~7 without hepatic encephalopathy, no clinically apparentascites or require medical intervention

8. ECOG performance status 0~1

9. Life expectancy ≥ 3 months

10. Adequate organ function and bone marrow function as indicated by the followingscreening assessments performed within 14 days prior to the first dose of study drug (without blood transfusion or medication with stimulation factors within 14 daysbefore 1st dose):

11. Absolute neutrophil count (ANC) ≥1.5×109/L

12. Platelet count (PLT) ≥75×109/L

13. Hemoglobin (Hb) ≥80 g/L

14. Total bilirubin (TBIL) ≤1.5×ULN

15. Aspartate transaminase (AST) and alanine transaminase (ALT), ≤3×ULN (forpatient with liver metastasis in escalation part or patient in expansion part:AST and AST ≤5×ULN)

16. Serum creatinine (Cr) ≤1.5×ULN or creatinine clearance (Crcl) ≥50 mL/min basedon Cockcroft-Gault formula

17. Patients with HBV infection should follow local clinical practice and anti-HBVtherapy should be performed to ensure adequate viral suppression (HBV-DNA < 10000IU/mL or equivalent copies/mL prior to enrollment). Patients are examined everycycle to monitor HBV-DNA levels. If virus reactivation occurred for patients withoutanti-viral treatment when enrolled, anti-HBV therapy will be started following localpractice.

18. Non-surgically sterilized male or female patients of childbearing potential mustagree to use effective methods of birth control during the study and for up to 6months after the last dose of study drug. Non-surgically sterilized female patientsof childbearing potential must in non-lactation period, and have a negative β-HCGtest result within 7 days before first administration.

19. Patient should understand, sign, and date the written voluntary informed consentform prior to any protocol-specific procedures performed. Patient should be able andwilling to comply with study visits and procedures as per protocol.

Exclusion Criteria:

1. Known allergy or hypersensitivity to any component of the investigational drugproduct.

2. Previous treatment with FGFR4 or pan-FGFR pathway inhibitors (pan-FGFR inhibitorsshould be confirmed with the sponsor).

3. Has a known second primary malignancy required active treatment.

4. Has a known active central nervous system (CNS) metastases (if stable disease aftertreatment, free from or daily dexamethasone <10 mg or other equivalentglucocorticoids can be enrolled).

5. Liver tumor volume accounts for ≥50% of the whole liver.

6. Inability to take oral medication or other factors significant preclude adequateabsorption of oral medication, such as previously received total gastrectomy,residual gastric dysfunction after subtotal gastrectomy, short bowel syndrome aftersmall bowel resection, active diarrhea required drug treatment, etc.

7. Severe irritable bowel syndrome requires drug therapy.

8. Prior organ transplantation requires anti-rejection drug therapy.

9. Previous anti-cancer therapy prior to initiation of study treatment: major surgery (except palliative therapy), radiotherapy (bone-marrow exposure >30%), routinechemotherapy <4 weeks (chemotherapy with nitrosourea or mitomycin <6 weeks); oralchemotherapy, endocrine therapy, molecular targeted therapy or immunotherapy within ≤ 5 half-life or ≤ 4 weeks (whichever is shorter).

10. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies,including immunotherapy that have not regressed to Grade ≤1 severity (CTCAE v5.0)with the exception of which inclusion criteria allowed, alopecia, vitiligo andneurotoxicity Grade ≤2 that investigator believe don't affect safety assessment.

11. Concomitant use of strong inhibitors or inducers of CYP3A4 (include grapefruitjuice, grapefruit hybrids, pomegranates, starfruit, pomelos, Seville oranges orjuice or products) within at least 14 day prior to the first dose of the study drug.

12. Impaired cardiac function or clinically significant cardiac disease, including anyone of the following:

13. New York Heart Association class III or IV congestive heart failure, unstableangina, or myocardial infarction within 6 months before administration of thestudy drug;

14. Clinically significant cardiac arrhythmia requiring active therapy;

15. Uncontrolled hypertension;

16. Left ventricle ejection fraction<50%

17. Prolongation of QTcF (average of three times of examine, male > 450 ms, female > 470 ms) (Note: QTc interval corrected by Frederica's formula) at screening,and other ECG abnormalities with clinical significant by the judge of theinvestigator.

18. Active infection or unexplained fever > 38.5℃.

19. Active or record of gastrointestinal bleeding within 6 months (e.g. esophagealvarices or ulcer bleeding).

20. Patients with active HCV infection (HCV-RNA>103 copies/mL or following localclinical practice) and require concomitant anti-HCV therapy during the study; or HBVHCV co-infection.

21. History of immunodeficiency, including HIV serum test positive, or otheracquired/congenital immunodeficiency disease, or active tuberculosis.

22. Any other clinically significant comorbidities, such as respiratory, metabolic,congenital, endocrine or central nervous system disease, or any other medicalconditions, mental disturbances or social determinants, which in the judgment of theInvestigator, could compromise compliance with the protocol, interfere with theinterpretation of study results, or predispose the patient to safety risks.

23. Combined with portal vein tumor thrombus of type IV.