Open
Actively Recruiting
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
About
Brief Summary
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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)
Join this Trial
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Study Stats
Protocol No.
21-000722
Category
Lung Cancer
Other Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica