A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
NCT ID: NCT04913285
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
400 participants
INTERVENTIONAL
2021-08-04
2029-03-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Monotherapy (Part A1)
Dose escalation of KIN-2787
KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles
Dose Escalation Combination therapy (Part A2)
Dose escalation of KIN-2787 and binimetinib
KIN-2787 and binimetinib
Continuous and Ramp-Up cohorts: KIN-2787 (exarafenib) and binimetinib will be administered orally twice daily in 28-day cycles Intermittent Cohort: KIN-2787 will be administered orally twice daily and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles
Dose Expansion Monotherapy (Part B1)
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787
KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles
Dose Escalation Combination therapy (Part B2)
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib
KIN-2787 and binimetinib
Continuous and Ramp-Up cohorts: KIN-2787 (exarafenib) and binimetinib will be administered orally twice daily in 28-day cycles Intermittent Cohort: KIN-2787 will be administered orally twice daily and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles
Interventions
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KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles
KIN-2787 and binimetinib
Continuous and Ramp-Up cohorts: KIN-2787 (exarafenib) and binimetinib will be administered orally twice daily in 28-day cycles Intermittent Cohort: KIN-2787 will be administered orally twice daily and binimetinib will be administered twice daily for 5 days on, 2 days off for 28-day cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic or advanced stage solid tumor
* Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA.
* Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
* ECOG performance status 0-1
* Adequate organ function, as measured by laboratory values (criteria listed in protocol).
* Able to swallow, retain, and absorb oral medications.
Exclusion Criteria
* In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
* GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
* Active, uncontrolled bacterial, fungal, or viral infection.
* Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is excluded
* Women who are lactating or breastfeeding, or pregnant.
* Participants with any other active treated malignancy within 3 years prior to enrollment
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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CLaire FABRE, MD
Role: STUDY_CHAIR
Pierre Fabre Laboratories
Locations
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The Angeles Clinic
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
University of California San Diego, Moores Cancer Center
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford Cancer Center
Stanford, California, United States
Sarah Cannon Research Institute Denver
Denver, Colorado, United States
Mayo Clinic - Florida
Jacksonville, Florida, United States
Sarah Cannon Research Institute - Florida Cancer Specialists
Orlando, Florida, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Atlantic Health
Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 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
Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Calvary Mater Hospital Newcastle
Waratah, New South Wales, Australia
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Tasman Health Care
Southport, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
Linear Clinical Research
Perth, Western Australia, Australia
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, China
Linyi Cancer Hospital
Linyi, Shandong, China
Beijing University Cancer Hospital
Beijing, , China
The Shanghai Pulmonary Hospital
Shanghai, , 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, , France
Gustave Roussy
Villejuif, , France
Istituto Nazionale dei Tumori Fondazione G. Pascale
Napoli, , 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, , Spain
Hospital General Gregorio Marañón
Madrid, , Spain
INCLIVA (Hospital Clinico de Valencia)
Valencia, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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KIN 2787CI101
Identifier Type: OTHER
Identifier Source: secondary_id
KN-8701
Identifier Type: -
Identifier Source: org_study_id