Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Futibatinib

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

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

Futibatinib and Binimetinib

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

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.

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

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

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

Plasma concentrations of futibatinib, binimetinib, and AR00426032

DOR is defined as the length of time between first response and the date of objectively documented progression of disease or death

PFS is defined as the time from date of first dose to objectively documented progression of disease or death

DCR is defined as the percentage of patients who have achieved a CR, PR, or SD.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer	NCT04965818	Advanced or Met... Non-Small Cell ... KRAS Gene Mutat...	Futibatinib and...	18 Years -	Taiho Oncology, Inc.
Phase 1b/2 Study of Futibatinib in Combination With Binimetinib in Patients With Advanced KRAS Mutant Cancer	NCT04965818	Advanced or Met... Non-Small Cell ... KRAS Gene Mutat...	Futibatinib and...	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for futibatinib and binimetinib