Clinical trial · Interventional
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
A Phase 1b/2 Open-label, Nonrandomized Study of FGFR Inhibitor Futibatinib in Combination With MEK-inhibitor Binimetinib in Patients With Advanced KRAS Mutant Cancer
NCT04965818CI-TRIAL-00080792terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic decision by sponsor.
Summary
Brief summary (as posted)
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations | — | UNRESOLVED | — |
| KRAS Gene Mutation | — | UNRESOLVED | — |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Futibatinib and Binimetinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Futibitanib in combination with binimetinib
- description
- Dose escalation: Futibitanib in combination with binimetinib in patients with advanced cancer disease. Dose expansion: Futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC
- interventionNames
- Drug: Futibatinib and Binimetinib
Primary outcomes (2)
- measure
- Recommended Phase 2 Dose (RP2D) in Part 1
- timeFrame
- 12 months
- description
- Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities
- measure
- Objective Response Rate (ORR) in Part 2
- timeFrame
- approximately 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDRodon J, O'Neil B, Lim C, Ammakkanavar NR, Torrado C, Matsuoka K, Hirai H, Miura A, Anderson B, Jin L, Hangai N, Long A, Wacheck V, Rosen L. Preclinical and clinical evaluation of futibatinib in combination with binimetinib in patients with advanced cancer. Invest New Drugs. 2026 May 18. doi: 10.1007/s10637-026-01618-y. Online ahead of print. PMID 42149426