Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)

Inclusion Criteria:

   - Histologically or cytologically confirmed solid tumor malignancy that is advanced or
   metastatic or is surgically unresectable.

   - Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain
   tumors). Tumor lesions located in a previously irradiated area or in an area subjected
   to other loco-regional therapy are considered measureable if progression has been
   clearly demonstrated in the lesion.

   - Documentation of an FGFR1-3 gene mutation or translocation.

   - Objective progression after at least 1 prior therapy and no therapy available that is
   likely to provide clinical benefit. Participants who are intolerant to or decline the
   approved therapy are eligible only if they have no therapy available that is likely to
   provide clinical benefit.

   - Eastern Cooperative Oncology Group performance status 0 to 2.

   - Baseline archival tumor specimen (if less than 24 months from date of screening) or
   willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a
   tumor block or approximately 15 unstained slides from biopsy or resection of primary
   tumor or metastasis.

   - Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

   - Prior receipt of a selective FGFR inhibitor in the past 6 months.

   - Receipt of anticancer medications or investigational drugs for any indication or
   reason within 28 days before first dose of pemigatinib.

   - Cannot be a candidate for potentially curative surgery.

   - Current evidence of clinically significant corneal or retinal disorder as confirmed by
   ophthalmologic examination.

   - Radiation therapy administered within 2 weeks of enrollment/first dose of study
   treatment.

   - Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases
   that have progressed (eg, evidence of new or enlarging brain metastasis or new
   neurological symptoms attributable to brain or CNS metastases).

   - Known additional malignancy that is progressing or requires active treatment.

   - History of calcium and phosphate hemostasis disorder or systemic mineral imbalance
   with ectopic calcification of soft tissues.

   - Clinically significant or uncontrolled cardiac disease.

   - Active chronic or current infectious disease requiring systemic antibiotic,
   antifungal, or antiviral treatment within 2 weeks before enrollment (participants with
   asymptomatic chronic infections on prophylactic treatment are allowed).

   - Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
   (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no
   cirrhosis and no elevated transaminases is allowed).

   - Known HIV infection.

   - Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14
   days or five half-lives (whichever is longer) before the first dose of study
   drug/treatment.

   - Women who are pregnant or breastfeeding.