Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies – (FIGHT-101)

Inclusion Criteria:

Male or female subjects, age 18 years or older on day of signing consent
Part 1: Any advanced solid tumor malignancy; Part 2: Subjects with squamous non-small cell lung cancer, cholangiocarcinoma/gastric cancer, urothelial cancer, breast/endometrial cancer, multiple myeloma, or MPNs that have a tumor or malignancy that has been evaluated and confirmed to harbor genetic alterations in FGF or FGFR genes. A subject's fibroblast growth factor (FGF) or fibroblast growth factor receptor (FGFR) alteration may be based on local or central laboratory results. Part 3: Dose finding: subjects with solid tumor malignancies who qualify for combo therapy; dose-expansion: FGF/FGFR+ subjects qualified to receive combo therapy
Has progressed after prior therapy and there is no further effective standard anticancer therapy available (including subject refuses or is intolerant)
Life expectancy > 12 weeks

Eastern Cooperative Oncology Group (ECOG) performance status:

Part 1: 0 or 1
Part 2 and 3: 0, 1, or 2

Exclusion Criteria:

Treatment with other investigational study drug for any indication for any reason, or receipt of anticancer medications within 21 days or 5 half-lives before first dose of study drug
Prior receipt of a selective FGFR inhibitor
History of a calcium/phosphate homeostasis disorder
History and/or current evidence of ectopic mineralization/calcification
Current evidence of corneal disorder/keratopathy
Has a history or presence of inadequate liver, renal, hematopoietic and/or cardiac function parameters outside protocol-defined range
Prior radiotherapy within 2 weeks of study treatment