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

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.
• Treatments: Futibatinib

Criteria

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 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)