We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04965818
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Phase 1b/2 study to evaluate the FGFRi futibatinib in combination with the MEKi binimetinib in patients with advanced KRASmt tumors.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations Non-Small Cell Lung Cancer KRAS Gene Mutation Drug: Futibatinib and Binimetinib Phase 1 Phase 2

Detailed Description:

This is an open-label, nonrandomized, uncontrolled Phase 1b/2 study to determine the recommended phase 2 dose (RP2D) of futibatinib in combination with binimetinib and to explore the preliminary antitumor activity of futibatinib in combination with binimetinib in patients with advanced KRASmt tumors.

The study will consist of two parts:

  • Part 1: Dose-Escalation part to determine the RP2D and dosing schedule of futibatinib in combination with binimetinib in patients with advanced cancer disease
  • Part 2: Dose-Expansion part to evaluate the preliminary antitumor activity of futibatinib in combination with binimetinib at the RP2D in patients with advanced KRASmt NSCLC

Patients will receive study treatment until progressive disease or any other discontinuation or withdrawal criterion is met.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 20, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Binimetinib

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Futibitanib in combination with binimetinib

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) in Part 1 [ Time Frame: 12 months ]
    Determine RP2D of futibatinib in combination with binimetinib based on Dose Limiting Toxicities

  2. Objective Response Rate (ORR) in Part 2 [ Time Frame: approximately 24 months ]
    proportion of patients who have achieved a PR or complete response (CR) according to RECIST 1.1.


Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of futibatinib, binimetinib, and AR00426032 [ Time Frame: approximately 24 months ]
    Plasma concentrations of futibatinib, binimetinib, and AR00426032

  2. PK: Area under the plasma concentration-time curve (AUC) of futibatinib, binimetinib, and AR00426032 [ Time Frame: approximately 24 months ]
    Plasma concentrations of futibatinib, binimetinib, and AR00426032

  3. PK: Time to reach maximum plasma concentration (Tmax) of futibatinib, binimetinib, and AR00426032 [ Time Frame: approximately 24 months ]
    Plasma concentrations of futibatinib, binimetinib, and AR00426032

  4. PK: Terminal elimination half-life (T1/2) of futibatinib, binimetinib, and AR00426032 [ Time Frame: approximately 24 months ]
    Plasma concentrations of futibatinib, binimetinib, and AR00426032

  5. PK: Minimum plasma concentration before administration (Cmin) of futibatinib, binimetinib, and AR00426032 [ Time Frame: approximately 24 months ]
    Plasma concentrations of futibatinib, binimetinib, and AR00426032

  6. PK: Accumulation ratio of Cmax and AUC (R) of futibatinib, binimetinib, and AR00426032 [ Time Frame: approximately 24 months ]
    Plasma concentrations of futibatinib, binimetinib, and AR00426032

  7. Duration of response (DOR) [ Time Frame: approximately 24 months ]
    DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death

  8. Progression-free survival (PFS) [ Time Frame: approximately 24 months ]
    PFS is defined as the time from date of first dose to objectively documented progression of disease or death

  9. Disease control rate (DCR) at 24 months [ Time Frame: approximately 24 months ]
    DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.

  10. Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Approximately 24 months ]
    Evaluate safety and tolerability of futibatinib in combination with binimetinib based on treatment-emergent adverse events per CTCAE v5.0(including serious adverse events),clinical laboratory parameters, ECGs, and vital signs


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04965818


Contacts
Layout table for location contacts
Contact: Taiho Oncology, INC 609-250-7336 clinicaltrialinfo@taihooncology.com

Locations
Layout table for location information
United States, California
University of California Los Angeles UCLA Cancer Recruiting
Santa Monica, California, United States, 90404
Contact: Christopher Lim    310-633-8400    ChristopherLim@mednet.ucla.edu   
Principal Investigator: Lee Rosen         
United States, Indiana
Community Cancer Center North Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Cindy Stoner    317-621-3836    cstoner@ecommunity.com   
Principal Investigator: Bert O'Neil         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jordi Rodon Ahnert, MD, PhD    713-563-1930      
Principal Investigator: Jordi Rodon Ahnert         
Sponsors and Collaborators
Taiho Oncology, Inc.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04965818    
Other Study ID Numbers: TAS-120-204
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: October 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
Futibatinib
Binimetinib
MEKi
FGFR
 FGFRi
TAS-120
KRASmt
NSCLC
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Futibatinib
Antineoplastic Agents