Recruiting
Phase 1

KIN-2787

Sponsor:

Pierre Fabre Medicament

Code:

NCT04913285

Conditions

Solid Tumor, Adult

Non-small Cell Lung Cancer

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

KIN-2787

KIN-2787 and binimetinib

Study Details

Brief summary:

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.

Conditions

Solid Tumor, Adult

Non-small Cell Lung Cancer

Melanoma

Study ID

NCT04913285

Start date

Aug 4, 2021

Status verified date

Dec, 2025

Completion date

Mar 30, 2029

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

400 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation Monotherapy (Part A1)

Dose escalation of KIN-2787

experimental: Dose Escalation Combination therapy (Part A2)

Dose escalation of KIN-2787 and binimetinib

experimental: Dose Expansion Monotherapy (Part B1)

Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787

experimental: Dose Escalation Combination therapy (Part B2)

Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib

Interventions

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

Primary outcome measure

  • Part A1 Dose escalation monotherapy: [ Time Frame: 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) ]
  • 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) ]
  • In Part B (Dose Expansion) - disease control rate (DCR). [ Time Frame: 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) ]
  • In Part B (Dose Expansion) - duration of stable disease. [ Time Frame: Initiation of study drug until disease progression (up to approximately 36 months) ]

Central Contacts and Locations

Central contacts

Data Protection Officer

00 33 684752268dpofr@pierre-fabre.com

Locations

The Angeles Clinic

Recruiting

Los Angeles, California, United States, 90025-6602

Contacts

Saba Mukarram

310-231-2121smukarram@theangelesclinic.org

Principal Investigator:

Omid Hamid, MD

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jessica Crocker

562-201-7669JCrocker@mednet.ucla.edu

Principal Investigator:

Bartosz Chmielowski, MD

University of California San Diego, Moores Cancer Center

Recruiting

San Diego, California, United States, 92093

Contacts

Nidhi Patel

1-858-822-0201nidpatel@health.ucsd.edu

Principal Investigator:

Shumei Kato, MD

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143-2205

Contacts

Michael Wong

415-514-6714michael.wong2@ucsf.edu

Principal Investigator:

Adil Daud, MD

Sarah Cannon Research Institute Denver

Recruiting

Denver, Colorado, United States, 80218-1238

Contacts

Josh Gordon

720-754-2610Joshua.Gordon@sarahcannon.com

Principal Investigator:

Ryan Weight, MD

Mayo Clinic - Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Ruqin Chen, MD

855-776-0015Chen.Ruqin@mayo.edu

Principal Investigator:

Ruqin Chen, MD

Sarah Cannon Research Institute - Florida Cancer Specialists

Recruiting

Orlando, Florida, United States, 32827

Contacts

asksarah@sarahcannon.com

Principal Investigator:

Cesar Perez Batista, MD

Mayo Clinic - Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Arkadiusz Dudek, MD

855-776-0015Dudek.Arkadiusz@mayo.edu

Principal Investigator:

Arkadiusz Dudek, MD

Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Salome Geene, RN

973-971-6373salome.geene@atlantichealth.org

Principal Investigator:

Eric Whitman, MD

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Kassie A. DiOrio

Kassie.Diorio@rutgers.edu

Principal Investigator:

Sarah Weiss, MD

NYU Langone

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Janice Mehnert, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

TaussigResearch@ccf.org

216-444-7923

Principal Investigator:

Dale Shepard, MD, PhD

Sarah Cannon Research Institute-Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

1(844) 482-4812

Principal Investigator:

Meredith McKean, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Carrie Friedman, RN, BSN, OCN

1-703-636-1473vcsclinicaltrials@usoncology.com

More Information

Sponsor

Pierre Fabre Medicament

Last update posted

Sep 2, 2026

Last verified

Dec, 2025

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Pierre Fabre Medicament on 2026-09-02.