A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Recruiting · NCT04913285 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
KIN-2787KIN-2787 and binimetinib
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Provide written informed consent prior to initiation of any study-specific procedures.
- 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
- Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain 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
- Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Where it is running
48 locations listed across 10 US states.
- 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
- 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
- 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
- Hospital Quiron Dexeus - Barcelona, Spain
- Beijing University Cancer Hospital - Beijing, China
- Institut Bergonie - Bordeaux, France
- Centre Francois Baclesse - Caen, France
- Hospital Universitario Insular de Gran Canaria - Las Palmas de Gran Canaria, Spain
- CHU de Lille - Lille, France
- Centre Leon Berard - Lyon, France
- START Madrid - Madrid, Spain
- Hospital General Gregorio Marañón - Madrid, Spain
- APHM-CHU La Timone - Marseille, France
- CHU Nantes-Hotel Dieu - Nantes, France
- Istituto Nazionale dei Tumori Fondazione G. Pascale - Naples, Italy
- 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
- The Shanghai Pulmonary Hospital - Shanghai, China
- National Taiwan University Hospital - Taipei, Taiwan
- Oncopole Claudius Regaud - Toulouse, France
- INCLIVA (Hospital Clinico de Valencia) - Valencia, Spain
- Gustave Roussy - Villejuif, France
- Harbin Medical University Cancer Hospital - Haerbin, Heilongjiang, China
- Calvary Mater Hospital Newcastle - Waratah, New South Wales, Australia
- Melanoma Institute Australia - Wollstonecraft, New South Wales, Australia
- Tasman Health Care - Southport, Queensland, Australia
- Linyi Cancer Hospital - Linyi, Shandong, China
- 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
- Austin Health - Heidelberg, Victoria, Australia
- Linear Clinical Research - Perth, Western Australia, Australia