Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer

Inclusion Criteria

• Histologically confirmed advanced cancer of any tumor type (Part 1) or NSCLC with a confirmed KRAS mutation as determined by local results (Part 2)
• Appropriate candidate for experimental therapy
• For patients in Part 2 only: Patient has radiographically measurable disease per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Adequate cardiac function (Left ventricular ejection fraction (LVEF) ≥50% )
• Adequate organ function
• Must have tumor tissue specimen available (optional for patients in Part 1)

Exclusion Criteria

• History or current evidence of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues
• Current evidence or history of clinically significant corneal or retinal disorder as confirmed by ophthalmologic examination.
• Known untreated central nervous system (CNS) metastases or history of uncontrolled seizures.
• Significant gastrointestinal disorder(s) that could interfere with absorption of futibatinib/binimetinib
• Patients who have neuromuscular disorders that are associated with elevated creatinine kinase (CK)