A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Start Date
8/4/2021
Completion Date
3/30/2029
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.
Detailed Description
This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor. The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class I, II or III mutations, including lung cancer, melanoma, and other selected solid tumors.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
KIN-2787
KIN-2787 and binimetinib
Conditions
Locations
The Angeles Clinic
Los Angeles, California 90025-6602
United States
UCLA
Los Angeles, California 90095
United States
University of California San Diego, Moores Cancer Center
San Diego, California 92093
United States
University of California San Francisco
San Francisco, California 94143-2205
United States
Sarah Cannon Research Institute Denver
Denver, Colorado 80218-1238
United States
Mayo Clinic - Florida
Jacksonville, Florida 32224
United States
Sarah Cannon Research Institute - Florida Cancer Specialists
Orlando, Florida 32827
United States
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United States
Atlantic Health
Morristown, New Jersey 07960
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
NYU Langone
New York, New York 10016
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee 37203
United States
MD Anderson
Houston, Texas 77030
United States
Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Calvary Mater Hospital Newcastle
Waratah, New South Wales 2298
Australia
Melanoma Institute Australia
Wollstonecraft, New South Wales 2065
Australia
Tasman Health Care
Southport, Queensland 4215
Australia
Austin Health
Heidelberg, Victoria 3084
Australia
Linear Clinical Research
Perth, Western Australia 6009
Australia
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang 150081
China
Linyi Cancer Hospital
Linyi, Shandong 276001
China
Beijing University Cancer Hospital
Beijing, 100142
China
The Shanghai Pulmonary Hospital
Shanghai, 200433
China
Institut Bergonie
Bordeaux,
France
Centre Francois Baclesse
Caen,
France
CHU de Lille
Lille,
France
Centre Leon Berard
Lyon,
France
APHM-CHU La Timone
Marseille,
France
CHU Nantes-Hotel Dieu
Nantes,
France
CHU de Nice - Hôpital Archet 2
Nice,
France
APHP - Hôpital St Louis
Paris,
France
Hospices Civiles de Lyon - Hôpital Lyon Sud
Pierre-Bénite,
France
CHU de Poitiers
Poitiers,
France
Oncopole Claudius Regaud
Toulouse, 31059
France
Gustave Roussy
Villejuif, 94805
France
Istituto Nazionale dei Tumori Fondazione G. Pascale
Naples, 80131
Italy
Arance
Barcelona, Spain
Spain
NEXT Quirónsalud Madrid
Madrid, Spain
Spain
H. Regional de Málaga
Málaga, Spain
Spain
H. Virgen Macarena
Seville, Spain
Spain
Berrocal
Valencia, Spain
Spain
Hospital Quiron Dexeus
Barcelona,
Spain
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria,
Spain
START Madrid
Madrid, 28050
Spain
Hospital General Gregorio Marañón
Madrid, 29009
Spain
INCLIVA (Hospital Clinico de Valencia)
Valencia,
Spain
National Taiwan University Hospital
Taipei,
Taiwan