TrialPath
Recruiting

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

NCT04913285 · Pierre Fabre Medicament
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

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.
About this study
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
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.
Study design
Enrollment target: 400 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-08-04
Estimated completion: 2029-03-30
Last updated: 2026-09-02
Interventions
Drug: KIN-2787Drug: KIN-2787 and binimetinib
Primary outcomes
  • Part A1 Dose escalation monotherapy: (Initiation of study drug through 28 days after last dose (up to approximately 18 months))
  • Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination (Initiation of study drug through 28 days after last dose (up to approximately 18 months))
  • In Part B (Dose Expansion) - objective response rate (ORR) using RECIST v1.1. (Initiation of study drug until disease progression (up to approximately 36 months))
Sponsor
Pierre Fabre Medicament · industry
Contacts & investigators
ContactData Protection Officer · contact · dpofr@pierre-fabre.com · 00 33 684752268
InvestigatorData Protection Officer · study_chair, Pierre Fabre Laboratories
All locations (48)
The Angeles ClinicRecruiting
Los Angeles, California, United States
UCLARecruiting
Los Angeles, California, United States
University of California San Diego, Moores Cancer CenterRecruiting
San Diego, California, United States
University of California San FranciscoRecruiting
San Francisco, California, United States
Sarah Cannon Research Institute DenverRecruiting
Denver, Colorado, United States
Mayo Clinic - FloridaRecruiting
Jacksonville, Florida, United States
Sarah Cannon Research Institute - Florida Cancer SpecialistsRecruiting
Orlando, Florida, United States
Mayo Clinic - RochesterRecruiting
Rochester, Minnesota, United States
Atlantic HealthRecruiting
Morristown, New Jersey, United States
Rutgers Cancer Institute of New JerseyRecruiting
New Brunswick, New Jersey, United States
NYU LangoneRecruiting
New York, New York, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Sarah Cannon Research Institute-Tennessee OncologyRecruiting
Nashville, Tennessee, United States
MD AndersonNot Yet Recruiting
Houston, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Calvary Mater Hospital NewcastleRecruiting
Waratah, New South Wales, Australia
Melanoma Institute AustraliaRecruiting
Wollstonecraft, New South Wales, Australia
Tasman Health CareRecruiting
Southport, Queensland, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Linear Clinical ResearchRecruiting
Perth, Western Australia, Australia
Harbin Medical University Cancer HospitalRecruiting
Haerbin, Heilongjiang, China
Linyi Cancer HospitalActive Not Recruiting
Linyi, Shandong, China
Beijing University Cancer HospitalActive Not Recruiting
Beijing, China
The Shanghai Pulmonary HospitalActive Not Recruiting
Shanghai, China
Institut BergonieRecruiting
Bordeaux, France
Centre Francois BaclesseRecruiting
Caen, France
CHU de LilleRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
APHM-CHU La TimoneRecruiting
Marseille, France
CHU Nantes-Hotel DieuRecruiting
Nantes, France
CHU de Nice - Hôpital Archet 2Recruiting
Nice, France
APHP - Hôpital St LouisRecruiting
Paris, France
Hospices Civiles de Lyon - Hôpital Lyon SudRecruiting
Pierre-Bénite, France
CHU de PoitiersRecruiting
Poitiers, France
Oncopole Claudius RegaudRecruiting
Toulouse, France
Gustave RoussyRecruiting
Villejuif, France
Istituto Nazionale dei Tumori Fondazione G. PascaleRecruiting
Naples, Italy
AranceRecruiting
Barcelona, Spain, Spain
NEXT Quirónsalud MadridRecruiting
Madrid, Spain, Spain
H. Regional de MálagaRecruiting
Málaga, Spain, Spain
H. Virgen MacarenaRecruiting
Seville, Spain, Spain
BerrocalRecruiting
Valencia, Spain, Spain
Hospital Quiron DexeusRecruiting
Barcelona, Spain
Hospital Universitario Insular de Gran CanariaRecruiting
Las Palmas de Gran Canaria, Spain
START MadridRecruiting
Madrid, Spain
Hospital General Gregorio MarañónRecruiting
Madrid, Spain
INCLIVA (Hospital Clinico de Valencia)Recruiting
Valencia, Spain
National Taiwan University HospitalActive Not Recruiting
Taipei, Taiwan