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

Taiho Oncology, Inc.

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Pharmaceutical Solutions

Vaccines

Trametinib

Dabrafenib

Monatide (IMS 3015)

Vemurafenib

Immunologic Factors

The vaccine drug product, 6MHP, consists of 6 class II MHC-restricted peptides derived from melanoma proteins. Each vaccine consists of 200 mcg of each of the six peptides. An aqueous solution of vaccine is mixed 1/1 with Montanide ISA-51 to form water-in-oil emulsions. Vaccines are administered days 1, 8, 15, 36, 57, 78. All peptide vaccines are administered intradermally and subcutaneously.

A selective BRAF inhibitor and a selective MEK inhibitor will be administered in accordance with the prescribing information.

BRAF inhibitor

6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides

6MHP

MEK inhibitor

Elizabeth Gaughan, MD

Craig L. Slingluff, Jr., MD

This study evaluates whether it is safe to administer a helper peptide vaccine with BRAF inhibitor and MEK inhibitor therapy. This study will also evaluate the effects of the combination of the peptide vaccine and BRAF inhibitors/MEK inhibitors on the immune system. We will monitor these effects by performing tests in the laboratory on participants' blood and tumor samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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.
A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib	NCT02382549	Melanoma	BRAF inhibitor 6MHP MEK inhibitor	18 Years -	University of Virginia
A Clinical Trial to Evaluate a Melanoma Helper Peptide Vaccine Plus Dabrafenib and Trametinib	NCT02382549	Melanoma	BRAF inhibitor 6MHP MEK inhibitor	18 Years -	University of Virginia
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 meki

Every month we try and update this database with for meki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for meki

Every month we try and update this database with for meki cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for meki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.