NCT04965818

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2021

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 16, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

July 6, 2021

Last Update Submit

September 6, 2024

Conditions

Advanced or Metastatic Solid Tumors Irrespective of Gene AlterationsNon-Small Cell Lung CancerKRAS Gene Mutation

Keywords

FutibatinibBinimetinibMEKiFGFRFGFRiTAS-120KRASmtNSCLC

Outcome Measures

Primary Outcomes (2)

  • Recommended Phase 2 Dose (RP2D) in Part 1

    Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities

    12 months

  • Objective Response Rate (ORR) in Part 2

    proportion of patients who have achieved a PR or complete response (CR) according to RECIST 1.1.

    approximately 24 months

Secondary Outcomes (10)

  • Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032

    approximately 24 months

  • PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032

    approximately 24 months

  • PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032

    approximately 24 months

  • PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032

    approximately 24 months

  • PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032

    approximately 24 months

  • +5 more secondary outcomes

Study Arms (1)

Futibitanib in combination with binimetinib

EXPERIMENTAL

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

Drug: Futibatinib and Binimetinib

Interventions

Futibatinib and BinimetinibDRUG

Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle

Futibitanib in combination with binimetinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California Los Angeles UCLA Cancer

Santa Monica, California, 90404, United States

Location

Community Cancer Center North

Indianapolis, Indiana, 46250, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

futibatinibbinimetinib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 16, 2021

Study Start

September 20, 2021

Primary Completion

June 11, 2023

Study Completion

September 21, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(3)