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Brief Title: A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Official Title: A Phase 1/1b Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Participants With BRAF and/or NRAS Mutation-positive Solid Tumors.
Study ID: NCT04913285
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
Providence, Fullerton, California, United States
UCSD Moores Cancer Center, La Jolla, California, United States
University of Southern California, Los Angeles, California, United States
UCLA, Los Angeles, California, United States
UC Davis, Sacramento, California, United States
Providence Medical Foundation (St. Joseph's), Santa Rosa, California, United States
Stanford Cancer Center, Stanford, California, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Sarah Cannon Research Institute - Lake Nona, Orlando, Florida, United States
Moffitt Cancer Ceter, Tampa, Florida, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
NYU Langone, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Melanoma Institute Australia, Wollstonecraft, New South Wales, Australia
Linear Clinical Research, Perth, Western Australia, Australia
Union Hospital of Tongji Medical College of HUST, Wuhan, Hubei, China
Linyi Cancer Hospital, Linyi, Shandong, China
Beijing University Cancer Hospital, Beijing, , China
The Shanghai Pulmonary Hospital, Shanghai, , China
Institut Bergonie, Bordeaux, , France
Centre Leon Berard, Lyon, , France
APHM-CHU La Timone, Marseille, , France
CHU Nantes-Hotel Dieu, Nantes, , France
Gustave Roussy, Villejuif, , France
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Netherlands Cancer Institute, Amsterdam, , Netherlands
Vall d'Hebron Institute of Oncology (VHIO), Barcelona, , Spain
Hospital Quiron Dexeus, Barcelona, , Spain
Hospital Universitario Insular de Gran Canaria, Las Palmas De Gran Canaria, , Spain
Hospital General Gregorio Marañón, Madrid, , Spain
INCLIVA (Hospital Clinico de Valencia), Valencia, , Spain
Taipei Veterans General Hospital, Taipei, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan