HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma

Inclusion Criteria:

1. Have fully understood the study and voluntarily signed the ICF;

2. Age ≥ 18 years;

3. a. pathologically or cytologically confirmed advanced treatment failure solid tumorwith standard patients (applicable to cohorts2 stage I); b. histologically orcytologically confirmed histologically or cytologically confirmed locally advancedunresectable or metastatic ICC patients with FGFR2 fusions/rearrangements/mutation (applicable to Cohort 1, Cohort 2 Stage II, Cohort 3 and Cohort 4)

4. a. The patients have received at least one prior systemic treatment regimen foradvanced ICC and has intolerable PD or toxicity(Cohort1-3); b. Patients who have notreceived any prior systemic therapy for advanced ICC(Cohort4)

5. Measurable lesion according to RECIST v1.1;

6. ECOG performance status of 0 or 1;

7. Life expectancy ≥ 12 weeks;

8. Female patients or male patients with partners of childbearing potential must takeeffective contraceptive measures per the protocol.

Exclusion Criteria:

1. Patients who previously received selective FGFR targeting therapy;

2. Received approved or researched systemic anti-tumor treatment within 3 weeks priorto the start of the study treatment;

3. Radical radiotherapy within 4 weeks;

4. Have received local anti-tumor treatment within 4 weeks;

5. Major surgery requiring hospitalization or incomplete healing of the surgeryincision within 4 weeks;

6. Current or prior history of retinal detachment;

7. Using a strong inducer or inhibitor of cytochrome P450 3A (CYP3A) within 2 weeks or 5 half-lives of the study treatment;

8. Taking drugs or dietary supplementsthat may cause blood phosphorus and/or bloodcalcium to rise within 2 weeks prior to the start of the study treatment;

9. International normalized ratio above 1.5 or partial activated prothrombin time above 1.5 times ULN;

10. History of clinically significant active hepatopathy, including active viralhepatitis, or other active hepatitis, clinically significant moderate to severeliver cirrhosis;

11. The patients with human immunodeficiency virus (HIV) infection;

12. Active infection requiring systemic treatment within 1 week prior to the start ofthe study treatment;

13. Screening blood phosphorus levels above ULN, or history of abnormal calciumphosphorus metabolism requiring clinical intervention or relevant medical history;

14. Currently keratopathy confirmed by ophthalmological examination;

15. Prior history of retinal detachment, or current diseases that may cause retinaldetachment;

16. Clinically significant arrhythmia or conduction abnormalities requiring clinicalintervention;

17. Patients with known deep venous thrombosis, treated with low molecular weightheparin (LMWH) or drugs with similar efficacy, and the investigator judges that thethrombosis is stable for ≥ 2 weeks ;

18. Toxicities caused by prior anti-tumor treatment have not recovered to grade 0 or 1;

19. The patient has any current disease or condition that affects drug absorption, orthe patient cannot be orally administered;

20. Combined with other malignant tumor or a history of other malignant tumor within 5years prior to study screening;

21. Patients currently has central nervous system metastases, meningeal metastases orspinal cord compression, except in individual cases;

22. Any other medical condition or clinically significant laboratory abnormalitiesjudged by the investigator would make the patients unsuitable to participate in thisstudy.