Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Inclusion Criteria:

1. Histologically or cytologically confirmed, locally advanced, metastatic, orunresectable intrahepatic of extrahepatic Cholangiocarcinoma.

2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement

3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA

4. Documentation of radiographic disease progression on the most recent prior therapy

5. Measurable disease

6. performance status 0 or 1

7. Adequate organ function

Exclusion Criteria:

1. History or current evidence of calcium and phosphate homeostasis disorder

2. Current evidence of clinically significant retinal disorder

3. Treatment with any of the following within the specified time frame prior to thefirst dose of futibatinib:

4. Major surgery within the previous 4 weeks (the surgical incision should befully healed prior to the first dose of futibatinib) and radiotherapy forextended field within 4 weeks or limited field radiotherapy within 2 weeks

5. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE),selective internal radiotherapy (SIRT) or ablation within 4 weeks

6. Any non investigational anticancer therapy within 3 weeks or have not recoveredfrom side effects of such therapy prior to futibatinib. Endocrine therapy isallowed for patients with breast or prostate cancer

7. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Anyinvestigational agent received within 5 half-lives of the drug or 4 weeks,whichever is shorter.

8. Patients with prior FGFR-directed therapy

9. A serious illness or medical condition(s) including (but not limited to) thefollowing:

10. Known brain metastasis (not including primary brain tumors) unless patient isclinically stable for ≥1 month

11. Known acute systemic infection

12. Myocardial infarction, severe/unstable angina, symptomatic congestive heartfailure (New York Heart Association [NYHA] Class III or IV New York HeartAssociation [NYHA] Classification) within the previous 2 months; if >2 months,cardiac function must be within normal limits and the patient must be free ofcardiac-related symptoms

13. Significant gastrointestinal disorder(s) that could interfere with theabsorption of futibatinib.

14. Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that in the judgment of the Investigator would make the patientinappropriate for entry into this study.

15. Known additional malignancy that is progressing or requires active treatment, withthe exception of patients with a prior or concurrent malignancy whose naturalhistory or treatment does not have the potential to interfere with the safety orantitumor assessment of the investigational regimen. Exceptions must be discussedwith the Sponsor prior to patient enrollment.

16. Pregnant or lactating female.

17. Known hypersensitivity or severe reaction to futibatinib or its excipients.