Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumors Harboring Activating FGFR Mutations or Translocations (FIGHT-208)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
• Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
• Documentation of an FGFR1-3 gene mutation or translocation.
• Objective disease progression after at least 1 prior therapy.
• Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

• Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
• Prior receipt of a selective FGFR inhibitor.
• Current evidence of clinically significant corneal or retinal disorder.
• History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.