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MEK Inhibitor

Futibatinib and Binimetinib for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to treat patients with advanced KRASmt tumors.

Eligible Conditions
  • Advanced or Metastatic Solid Tumors
  • Non-Small Cell Lung Cancer
  • KRAS Mutation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) in Part 2
Recommended Phase 2 Dose (RP2D) in Part 1
Secondary outcome measures
Disease control rate (DCR) at 24 months
Duration of response (DOR)
Number of patients with treatment-emergent adverse events as assessed by CTCAE v5.0
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Futibitanib in combination with binimetinibExperimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,546 Total Patients Enrolled

Media Library

Binimetinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04965818 — Phase 1
Solid Tumors Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04965818 — Phase 1
Binimetinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04965818 — Phase 1
Solid Tumors Research Study Groups: Futibitanib in combination with binimetinib

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to still join this experiment?

"Yes, the trial is still open for enrollment according to the most recent update on clinicaltrials.gov. This particular study was first posted on September 20th, 2021 and is enrolling 36 patients from 3 different locations."

Answered by AI

What are the two medications Futibatinib and Binimetinib used to treat?

"Futibatinib and Binimetinib can be used to target BRAF V600K mutations, metastatic melanoma, and unresectable melanoma."

Answered by AI

Are Futibatinib and Binimetinib novel drugs?

"There are 5 Phase 3 clinical trials and 66 ongoing clinical trials studying Futibatinib and Binimetinib. Royal Oak, Michigan is one of the many locations where these studies are taking place with a total of 3250 sites running clinical trials for Futibatinib and Binimetinib."

Answered by AI

What are the specific aims of this research project?

"The purpose of this 24-month clinical trial is to determine the RP2D in Part 1. Additionally, researchers will collect data on PK: Cmin and AUC of futibatinib, binimetinib, and AR00426032 as well as DOR."

Answered by AI

How many participants are included in this research?

"The research team requires 36 individuals that match the pre-determined inclusion criteria in order to commence this clinical trial. Potential participants can enrol at either University of California Los Angeles UCLA Cancer in Santa Monica, California or Community Cancer Center North in Indianapolis, Indiana."

Answered by AI

Has this kind of medical research been conducted before?

"66 studies involving Futibatinib and Binimetinib are ongoing worldwide in 1163 cities across 42 countries. The first study, sponsored by Pfizer, completed its Phase 1 & 2 drug approval stage in 2012 with results from 189 patients. In the 8 years since then, 24 additional studies have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer
2021. "Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965818.
~11 spots leftby Apr 2025
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