A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

Inclusion Criteria

• Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
• Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
• Have measurable disease per RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
• Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention. Key

Exclusion Criteria

• Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
• Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
• Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
• Received more than 2 prior FGFRi therapies
• Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.