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

April 22, 2026 updated by: Pierre Fabre Medicament

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.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Hospital Newcastle
      • Wollstonecraft, New South Wales, Australia, 2065
        • Melanoma Institute Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Tasman Health Care
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Linear Clinical Research
  • China
      • Beijing, China, 100142
        • Beijing University Cancer Hospital
      • Shanghai, China, 200433
        • The Shanghai Pulmonary Hospital
    • Heilongjiang
      • Haerbin, Heilongjiang, China, 150081
        • Harbin Medical University Cancer Hospital
    • Shandong
      • Linyi, Shandong, China, 276001
        • LinYi Cancer Hospital
  • France
      • Bordeaux, France
        • Institut Bergonie
      • Caen, France
        • Centre Francois Baclesse
      • Lille, France
        • CHU de LILLE
      • Lyon, France
        • Centre Léon Bérard
      • Marseille, France
        • APHM-CHU La Timone
      • Nantes, France
        • Chu Nantes-Hotel Dieu
      • Nice, France
        • CHU de Nice - Hôpital Archet 2
      • Paris, France
        • APHP - Hôpital St Louis
      • Pierre-Bénite, France
        • Hospices Civiles de Lyon - Hôpital Lyon Sud
      • Poitiers, France
        • CHU de Poitiers
      • Toulouse, France, 31059
        • Oncopole Claudius Regaud
      • Villejuif, France, 94805
        • Gustave Roussy
  • Italy
      • Naples, Italy, 80131
        • Istituto Nazionale dei Tumori Fondazione G. Pascale
  • Spain
      • Barcelona, Spain
        • Hospital Quiron Dexeus
      • Las Palmas de Gran Canaria, Spain
        • Hospital Universitario Insular de Gran Canaria
      • Madrid, Spain, 28050
        • START Madrid
      • Madrid, Spain, 29009
        • Hospital General Gregorio Marañón
      • Valencia, Spain
        • INCLIVA (Hospital Clinico de Valencia)
    • Spain
      • Barcelona, Spain, Spain
        • Arance
      • Madrid, Spain, Spain
        • NEXT Quirónsalud Madrid
      • Málaga, Spain, Spain
        • H. Regional de Málaga
      • Seville, Spain, Spain
        • H. Virgen Macarena
      • Valencia, Spain, Spain
        • Berrocal
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • Los Angeles, California, United States, 90025-6602
        • The Angeles Clinic
      • San Diego, California, United States, 92093
        • University of California San Diego, Moores Cancer Center
      • San Francisco, California, United States, 94143-2205
        • University of California San Francisco
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80218-1238
        • Sarah Cannon Research Institute Denver
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Florida
      • Orlando, Florida, United States, 32827
        • Sarah Cannon Research Institute - Florida Cancer Specialists
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute of New Jersey
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10016
        • NYU Langone
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute-Tennessee Oncology
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Monotherapy (Part A1)
Dose escalation of KIN-2787
Drug: KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles
Other Names:
  • exarafenib
Experimental: Dose Escalation Combination therapy (Part A2)
Dose escalation of KIN-2787 and binimetinib
Drug: 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 Names:
  • exarafenib and binimetinib
Experimental: Dose Expansion Monotherapy (Part B1)
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787
Drug: KIN-2787
KIN-2787 will be administered orally twice daily in 28-day cycles
Other Names:
  • exarafenib
Experimental: Dose Escalation Combination therapy (Part B2)
Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib
Drug: 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 Names:
  • exarafenib and binimetinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A1 Dose escalation monotherapy:
Time Frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
To determine the safety and tolerability of oral administration of KIN-2787 including dose-limiting toxicities (DLTs), and to identify the maximum tolerated dose (MTD) and/or the appropriate dose for further clinical investigation in Part B Dose Expansion.
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination
Time Frame: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
To determine the safety and tolerability of oral administration of KIN-2787 + binimetinib including DLTs, and to identify the MTD and/or the appropriate dose for further clinical investigation.
Initiation of study drug through 28 days after last dose (up to approximately 18 months)
In Part B (Dose Expansion) - disease control rate (DCR).
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of overall response (DOR).
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression
Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of stable disease.
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - objective response rate (ORR) using RECIST v1.1.
Time Frame: Initiation of study drug until disease progression (up to approximately 36 months)
To assess preliminary evidence of the anti-cancer activity of KIN-2787 and for (B2) KIN-2787 + binimetinib
Initiation of study drug until disease progression (up to approximately 36 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to AUC.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to Cmax.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to Cmax.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to AUC.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to tmax.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to AUC.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to Cmax.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Part B Dose Expansion: characterization of PK properties of KIN-2787, and for (B2) KIN-2787 + binimetinib including, but not limited to tmax.
Time Frame: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Investigators

  • Study Chair: Grazia Saturno, PhD, Pierre Fabre Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

March 30, 2029

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN-8701
  • KIN 2787CI101 (Other Identifier: Pierre Fabre Medicament)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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