A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma
About this trial
This is an interventional treatment trial for Solid Tumor, Adult focused on measuring BRAF inhibitor, BRAF, pan-RAF, pan-RAF inhibitor, RAF1, ARAF, BRAF alteration, BRAF Class II, BRAF Class III, V600, tumor growth inhibitor (TGI), melanoma, NSCLC, solid tumor, targeted therapy, BRAF Class I, NRAS, Metastatic, Unresectable, CRC, ATC, Colon, Thyroid, Advanced, Exarafenib, binimetinib
Eligibility Criteria
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.
- In Part B Dose Expansion, patients with BRAF Class I mutations are excluded.
- 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.
Sites / Locations
- City of Hope
- Providence
- UCSD Moores Cancer CenterRecruiting
- University of Southern California
- UCLARecruiting
- UC Davis
- Providence Medical Foundation (St. Joseph's)
- Stanford Cancer CenterRecruiting
- Orlando Health Cancer InstituteRecruiting
- Sarah Cannon Research Institute - Lake NonaRecruiting
- Moffitt Cancer CeterRecruiting
- Decatur Memorial HospitalRecruiting
- Center for Cancer and Blood Disorders
- NYU LangoneRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Cleveland ClinicRecruiting
- Fox Chase Cancer CenterRecruiting
- Thomas JeffersonRecruiting
- Sarah Cannon Research InstituteRecruiting
- Virginia Cancer SpecialistsRecruiting
- Northwest Medical Specialties
- Melanoma Institute AustraliaRecruiting
- Linear Clinical ResearchRecruiting
- Union Hospital of Tongji Medical College of HUST
- Linyi Cancer Hospital
- Beijing University Cancer Hospital
- The Shanghai Pulmonary Hospital
- Institut BergonieRecruiting
- Centre Leon BerardRecruiting
- APHM-CHU La TimoneRecruiting
- CHU Nantes-Hotel DieuRecruiting
- Gustave RoussyRecruiting
- Chungbuk National University Hospital
- Seoul National University Hospital
- Samsung Medical Center
- Netherlands Cancer Institute
- Vall d'Hebron Institute of Oncology (VHIO)Recruiting
- Hospital Quiron DexeusRecruiting
- Hospital Universitario Insular de Gran CanariaRecruiting
- Hospital General Gregorio MarañónRecruiting
- INCLIVA (Hospital Clinico de Valencia)Recruiting
- Taipei Veterans General Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dose Escalation Monotherapy (Part A1)
Dose Escalation Combination therapy (Part A2)
Dose Expansion Monotherapy (Part B1)
Dose Escalation Combination therapy (Part B2)
Dose escalation of KIN-2787
Dose escalation of KIN-2787 and binimetinib
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib