Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma

Inclusion Criteria:

1. ≥ 18 years of age at the time of signing the informed consent form (ICF).

2. Histologically or cytologically confirmed CCA/adenocarcinoma of biliary origin withradiological evidence of unresectable or metastatic disease.

3. Documentation of FGFR2 fusion/rearrangement gene status

4. Subjects must have received at least one line of prior chemotherapy and exactly oneFDA approved FGFR inhibitor.

Exclusion Criteria:

1. Prior receipt of two or more FGFR inhibitors, either approved or investigationaldrugs.

2. Subjects with known brain or central nervous system (CNS) metastases that haveradiologically or clinically progressed in the 28 days prior to initiation oftherapy. Subjects with asymptomatic brain/CNS metastases or treated brain/CNSmetastases that have been clinically stable for 14 days on steroids withoutescalation of steroids are eligible for enrollment.

3. Subjects with a known concurrent malignancy that is progressing or requires activetreatment. Exceptions include basal cell carcinoma of the skin, carcinoma in situ ofthe cervix, or other noninvasive or indolent malignancy, including those that havepreviously undergone potentially curative therapy.

4. Subjects who have received prior systemic therapy or investigational study drug ≤ 5half-lives or 14 days, whichever is shorter, prior to starting the study drug or whohave not recovered (grade ≤ 1 or at pretreatment baseline except tolerable grade 2alopecia, fatigue/asthenia, and neuropathy due to trauma) from adverse events (AEs)of prior therapy.

5. Concurrent anticancer therapy including chemo-, immune-, or radiotherapy. Hormonetherapy may be allowed with Sponsor approval.

6. Subjects who have received wide field radiotherapy ≤ 4 weeks or limited fieldradiation for palliation ≤ 2 weeks prior to starting the study drug or who have notrecovered from AEs of prior therapy.

7. Subjects with uncontrolled hypertension (defined as blood pressure of ≥ 150 mm Hgsystolic and/or ≥ 90 mm Hg diastolic despite adequate treatment withantihypertensive medications at screening)