Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Inclusion Criteria:

Histologically/cytologically confirmed advanced or metastatic solid tumors who have failed standard therapy or for whom no effective standard anti-cancer therapy exists
Documented PIK3CA mutations in all patients in dose escalation and expansion with or without documented genetic alterations in FGFR depending upon dose expansion cohort (either local or central determination)
Measurable disease defined by RECIST v1.1
ECOG performance status of ≤2

Exclusion Criteria:

Prior PI3Ki or selective FGFR inhibitor treatment (for patients enrolled to expansion part)
Colorectal cancer (for patients enrolled to expansion part)
Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting glucose ≥ 140 mg/dL / 7.8 mmol/L, history of clinically significant gestational diabetes mellitus or documented steroid-induced diabetes mellitus
Use of medications that increase serum levels of phosphorus and/or calcium
Inorganic phosphorus outside of normal limits
Total and ionized serum calcium outside of normal limits