New drug targets rare bile duct cancer in 235-Patient trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 tumor with standard patients (applicable to cohorts2 stage I); b. histologically or cytologically confirmed histologically or cytologically confirmed locally advanced unresectable 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 for advanced ICC and has intolerable PD or toxicity(Cohort1-3); b. Patients who have not received 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 take effective 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 prior to 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 surgery incision 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 blood calcium 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 viral hepatitis, or other active hepatitis, clinically significant moderate to severe liver cirrhosis; 11. The patients with human immunodeficiency virus (HIV) infection; 12. Active infection requiring systemic treatment within 1 week prior to the start of the study treatment; 13. Screening blood phosphorus levels above ULN, or history of abnormal calcium phosphorus 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 retinal detachment; 16. Clinically significant arrhythmia or conduction abnormalities requiring clinical intervention; 17. Patients with known deep venous thrombosis, treated with low molecular weight heparin (LMWH) or drugs with similar efficacy, and the investigator judges that the thrombosis 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, or the patient cannot be orally administered; 20. Combined with other malignant tumor or a history of other malignant tumor within 5 years prior to study screening; 21. Patients currently has central nervous system metastases, meningeal metastases or spinal cord compression, except in individual cases; 22. Any other medical condition or clinically significant laboratory abnormalities judged by the investigator would make the patients unsuitable to participate in this study.