Solid Tumor, AdultPhase 1NCT04913285
A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors
A Phase 1 study testing KIN-2787 and KIN-2787 and binimetinib in people with Solid Tumor, Adult and Non-small Cell Lung Cancer, run by Pierre Fabre Medicament at 48 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma
- What is being tested?
- KIN-2787 and KIN-2787 and binimetinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 48 sitesin 7 countries
- Study dates
- 4 Aug 2021to 30 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
48 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
48 sites in 7 countries
United States15 sites, 15 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
TaussigResearch@ccf.org, 216-444-7923
Dale Shepard, MD, PhD
- Recruiting
Sarah Cannon Research Institute Denver
Denver, Colorado, 80218-1238
Josh Gordon, 720-754-2610, Joshua.Gordon@sarahcannon.com
Ryan Weight, MD
- Recruiting
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Carrie Friedman, RN, BSN, OCN, 1-703-636-1473, vcsclinicaltrials@usoncology.com
- Not yet recruiting
MD Anderson
Houston, Texas, 77030
Dahlia Mack, 713-597-1352, dahmack@mdanderson.org
Hussein Tawbi, MD
- Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
Ruqin Chen, MD, 855-776-0015, Chen.Ruqin@mayo.edu
Ruqin Chen, MD
- Recruiting
The Angeles Clinic
Los Angeles, California, 90025-6602
Saba Mukarram, 310-231-2121 ext. 2181, smukarram@theangelesclinic.org
Omid Hamid, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Jessica Crocker, 562-201-7669, JCrocker@mednet.ucla.edu
Bartosz Chmielowski, MD
- Recruiting
Atlantic Health
Morristown, New Jersey, 07960
Salome Geene, RN, 973-971-6373, salome.geene@atlantichealth.org
Eric Whitman, MD
- Recruiting
Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee, 37203
1(844) 482-4812
Meredith McKean, MD
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Kassie A. DiOrio, Kassie.Diorio@rutgers.edu
Sarah Weiss, MD
- Recruiting
NYU Langone
New York, New York, 10016
CT.gov@nyulangone.org
Janice Mehnert, MD
- Recruiting
Sarah Cannon Research Institute - Florida Cancer Specialists
Orlando, Florida, 32827
asksarah@sarahcannon.com
Cesar Perez Batista, MD
- Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Arkadiusz Dudek, MD, 855-776-0015, Dudek.Arkadiusz@mayo.edu
Arkadiusz Dudek, MD
- Recruiting
University of California San Diego, Moores Cancer Center
San Diego, California, 92093
Nidhi Patel, 1-858-822-0201, nidpatel@health.ucsd.edu
Shumei Kato, MD
- Recruiting
University of California San Francisco
San Francisco, California, 94143-2205
Michael Wong, 415-514-6714, michael.wong2@ucsf.edu
Adil Daud, MD
France12 sites, 12 recruiting
- Recruiting
Institut Bergonie
Bordeaux
Antonie Italiano, +33 5 47 30 60 88, a.italiano@bordeaux.unicancer.fr
Antonie Italiano, MD
- Recruiting
Centre Francois Baclesse
Caen
Andreea Stefan, MD, 0033 2 31 45 52 91, a.stefan@baclesse.unicancer.fr
Andreea Stefan, MD
- Recruiting
CHU de Lille
Lille
Anthony Turpin, MD, 0033 3 20 44 54 61, anthony.turpin@chu-lille.fr
Anthony Turpin, MD
- Recruiting
Centre Leon Berard
Lyon
Philippe Cassier, +33 4 26 55 68 33, philippe.cassier@lyon.unicancer.fr
Philippe Cassier, MD
- Recruiting
APHM-CHU La Timone
Marseille
Caroline Gaudy, +33 (0) 4 91 38 75 94, mailto:caroline.gaudy@ap-hm.fr
- Recruiting
CHU Nantes-Hotel Dieu
Nantes
Stephanie Bordenave, +33 2 40 16 59 30, stephanie.bordenave@chu-nantes.fr
Stephanie Bordenave, MD
- Recruiting
CHU de Nice - Hôpital Archet 2
Nice
Henri Montaudie, MD, 0033 4 92 03 60 83, montaudie.h@chu-nice.fr
Henri Motaudie, MD
- Recruiting
APHP - Hôpital St Louis
Paris
Celeste Lebbe, MD, 0033 1 42 49 93 92, celeste.lebbe@aphp.fr
Celeste Lebbe, MD
- Recruiting
Hospices Civiles de Lyon - Hôpital Lyon Sud
Pierre-Bénite
Stephane Dalle, MD, 0033 4 78 86 16 79, stephane.dalle@chu-lyon.fr
Stephane Dalle, MD
- Recruiting
CHU de Poitiers
Poitiers
Nicolas Isambert, MD, 0033 5 49 44 45 48, nicolas.isambert@chu-poitiers.fr
Nicolas Isambert, MD
- Recruiting
Oncopole Claudius Regaud
Toulouse, 31059
Cecile Pages Laurent, MD, 0033 5 31 15 51 51, pageslaurent.cecile@iuct-oncopole.fr
Cecile Pages Laurent, MD
- Recruiting
Gustave Roussy
Villejuif, 94805
David Planchard, MD, + 33 (0)1 42 11 45 64, David.PLANCHARD@gustaveroussy.fr
David Planchard, MD
Spain10 sites, 10 recruiting
- Recruiting
Arance
Barcelona, Spain
Ana Arance, +34 932275402, AMARANCE@clinic.cat
Anna Arance
- Recruiting
Hospital Quiron Dexeus
Barcelona
María María González Cao, MD, +34 93 546 01 35, mgonzalezcao@oncorosell.com
María María González Cao, MD
- Recruiting
Hospital Universitario Insular de Gran Canaria
Las Palmas de Gran Canaria
Delvys Rodríguez, +34 928 44 17 38, drodabr@gobiernodecanarias.org
Delvys Rodríguez, MD
- Recruiting
NEXT Quirónsalud Madrid
Madrid, Spain
Valentina Boni, MD, (+34) 914521900 ext. 338901, vboni@nextoncology.eu
Valentina Boni, MD
- Recruiting
START Madrid
Madrid, 28050
+34 917 567 825
Irene Moreno, MD
- Recruiting
Hospital General Gregorio Marañón
Madrid, 29009
Antonio Calles Blanco, MD, + 34 914 26 95 16, antonio.calles@live.com
+ 34 915 86 81 15
- Recruiting
H. Regional de Málaga
Málaga, Spain
Miguel A Berciano, MD, (+34) 951308129, migueberci@gmail.com
Miguel A Berciano, MD
- Recruiting
H. Virgen Macarena
Seville, Spain
Luis de la Cruz, +34 629 310 196 ext. 611565, luis.cruz.sspa@juntadeandalucia.es
Luis de la Cruz
- Recruiting
Berrocal
Valencia, Spain
Alfonso Berrocal, +34 96.31.31.800 ext. 437635, berrocal.alf@gmail.com
Alfonso Berrocal
- Recruiting
INCLIVA (Hospital Clinico de Valencia)
Valencia
Valentina Gambardella, MD, +34 961 97 35 31/+34 961 97 4, valen.gambardella@gmail.com
Valentina Gambardella, MD
Australia5 sites, 5 recruiting
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Damien Kee, MD, damien.kee@austin.org.au
Damien Kee, MD
- Recruiting
Linear Clinical Research
Perth, Western Australia, 6009
Michael Millward, Professor, (08) 6382 5100, cancertrialsstartup@linear.org.au
- Recruiting
Tasman Health Care
Southport, Queensland, 4215
Andrew Hill, MD, 07 5613 2480 804, andrew.hill@tasmanhealthcare.com.au
Vishal Patel, 07 5613 2480 804, vishal@tasmanhealthcare.com.au
- Recruiting
Calvary Mater Hospital Newcastle
Waratah, New South Wales, 2298
Emily Munn, +61 (0)2 4014 3851, andre.vanderwesthuizen@calvarymater.org.au
Andre van der Westhuizen, MD
- Recruiting
Melanoma Institute Australia
Wollstonecraft, New South Wales, 2065
Florence Clampett, +61299117200
Georgina Long, MD
China4 sites, 1 recruiting
- Active, not recruiting
Beijing University Cancer Hospital
Beijing, 100142
- Recruiting
Harbin Medical University Cancer Hospital
Haerbin, Heilongjiang, 150081
+86 13845120210
Nicole Tasker, nicole@tasmanhealthcare.com.au
- Active, not recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276001
- Active, not recruiting
The Shanghai Pulmonary Hospital
Shanghai, 200433
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale dei Tumori Fondazione G. Pascale
Naples, 80131
Paolo Antonio Ascierto, MD, 3908117770388, p.ascierto@istitutotumori.na.it'
Paolo A Ascierto, MD
About this study
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.
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.
Read the 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.
- Conditions
- Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma
- Being tested
- KIN-2787, KIN-2787 and binimetinib
- 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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Melanoma, Neoplasm Metastasis, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIN-2787Drug
Also called exarafenib
KIN-2787 will be administered orally twice daily in 28-day cycles
KIN-2787 and binimetinibDrug
Also called exarafenib 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
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Monotherapy (Part A1) | Experimental | Dose escalation of KIN-2787 Receives: Drug: KIN-2787 |
| Dose Escalation Combination therapy (Part A2) | Experimental | Dose escalation of KIN-2787 and binimetinib Receives: Drug: KIN-2787 and binimetinib |
| Dose Expansion Monotherapy (Part B1) | Experimental | Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 Receives: Drug: KIN-2787 |
| Dose Escalation Combination therapy (Part B2) | Experimental | Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib Receives: Drug: KIN-2787 and binimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A1 Dose escalation monotherapy:
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.
Measured: Initiation of study drug through 28 days after last dose (up to approximately 18 months)
Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination
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.
Measured: 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.
To assess preliminary evidence of the anti-cancer activity of KIN-2787 and for (B2) KIN-2787 + binimetinib
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - disease control rate (DCR).
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of overall response (DOR).
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
In Part B (Dose Expansion) - duration of stable disease.
Measured: Initiation of study drug until disease progression (up to approximately 36 months)
Secondary outcomes (9)
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start4 Aug 2021
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Data Protection Officer, Study chair, Pierre Fabre Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913285
- Sponsor's protocol ID
- KN-8701
- Other IDs
- KIN 2787CI101
- Status last verified
- Dec 2025
- First submitted
- 18 May 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04913285
- Acronym / sponsor ID
- KN-8701
- Conditions
- Solid Tumor, Adult, Non-small Cell Lung Cancer, Melanoma
- Keywords
- BRAF inhibitor, BRAF, pan-RAF, pan-RAF inhibitor, RAF1, ARAF, BRAF alteration, BRAF Class II
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Monotherapy (Part A1) | Experimental | Drug: KIN-2787Dose escalation of KIN-2787 |
| Dose Escalation Combination therapy (Part A2) | Experimental | Drug: KIN-2787 and binimetinibDose escalation of KIN-2787 and binimetinib |
| Dose Expansion Monotherapy (Part B1) | Experimental | Drug: KIN-2787Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 |
| Dose Escalation Combination therapy (Part B2) | Experimental | Drug: KIN-2787 and binimetinibDose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 and binimetinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIN-2787Also: exarafenibKIN-2787 will be administered orally twice daily in 28-day cycles | Drug | Dose Escalation Monotherapy (Part A1), Dose Expansion Monotherapy (Part B1) |
| KIN-2787 and binimetinibAlso: exarafenib and binimetinibContinuous 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 | Drug | Dose Escalation Combination therapy (Part A2), Dose Escalation Combination therapy (Part B2) |
Primary outcome
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.
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.
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
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)
Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression
In Part B (Dose Expansion) - duration of stable disease.
Time frame: Initiation of study drug until disease progression (up to approximately 36 months)
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Data Protection Officer study chair
Pierre Fabre Laboratories
48 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KIN-2787 and KIN-2787 and binimetinib in people with Solid Tumor, Adult and Non-small Cell Lung Cancer, run by Pierre Fabre Medicament at 48 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, France, Spain, Australia, China and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Data Protection Officer (00 33 684752268, dpofr@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.