Clinical trial • Phase III • Oncology

KIN-2787 for BRAF and/or NRAS mutation-positive solid tumours

Phase III trial of KIN-2787 for BRAF and/or NRAS mutation-positive solid tumours. 321 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
BRAF and/or NRAS mutation-positive solid tumours
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
02-10-2024
First CTIS Authorization Date
15-10-2024

Trial design

Phase III trial across 27 sites in France, Spain, Italy and others.

Target Sample Size
321

Eligibility

Recruits 321 Vulnerable population not selected; no special consent or assent handling is described in the provided record..

Vulnerable Population
Vulnerable population not selected; no special consent or assent handling is described in the provided record.

Recruitment

Planned Sample Size
321
Recruitment Window Months
69

Geography

Total Number Of Sites
27
Total Number Of Participants
182

France

Earliest CTIS Part Ii Submission Date
16-10-2024
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
337
Number Of Sites
12
Number Of Participants
106

Sites

Site Name
Institut Bergonie
Department Name
Medical Oncology
Principal Investigator Name
Antoine Italiano
Principal Investigator Email
a.italiano@bordeaux.unicancer.fr
Contact Person Name
Antoine Italiano
Site Name
Hospices Civils De Lyon
Department Name
Oncology Department
Principal Investigator Name
Stephane Dalle
Principal Investigator Email
stephane.dalle@chu-lyon.fr
Contact Person Name
Stephane Dalle
Contact Person Email
stephane.dalle@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Oncology
Principal Investigator Name
Henri Montaudié
Principal Investigator Email
montaudie.h@chu-nice.fr
Contact Person Name
Henri Montaudié
Contact Person Email
montaudie.h@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Medical Oncology
Principal Investigator Name
Jeanne Chen
Principal Investigator Email
jeanne.chen@chu-nantes.fr
Contact Person Name
Jeanne Chen
Contact Person Email
jeanne.chen@chu-nantes.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Oncology Department
Principal Investigator Name
Caroline Gaudy
Principal Investigator Email
caroline.gaudy@ap-hm.fr
Contact Person Name
Caroline Gaudy
Contact Person Email
caroline.gaudy@ap-hm.fr
Site Name
Institut Gustave Roussy
Department Name
Oncology
Principal Investigator Name
David Planchard
Principal Investigator Email
david.planchard@gustaveroussy.fr
Contact Person Name
David Planchard
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Oncology Department
Principal Investigator Name
Nicolas Isambert
Principal Investigator Email
Nicolas.ISAMBERT@chu-poitiers.fr
Contact Person Name
Nicolas Isambert
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Oncology Department
Principal Investigator Name
Anthony Turpin
Principal Investigator Email
Anthony.TURPIN@chu-lille.fr
Contact Person Name
Anthony Turpin
Contact Person Email
Anthony.TURPIN@chu-lille.fr
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Principal Investigator Name
Philippe Cassier
Principal Investigator Email
philippe.cassier@lyon.unicancer.fr
Contact Person Name
Philippe Cassier
Site Name
Oncopole Claudius Regaud
Department Name
Oncology Department
Principal Investigator Name
Cécile Pages
Principal Investigator Email
PagesLaurent.Cecile@iuct-oncopole.fr
Contact Person Name
Cécile Pages
Site Name
Centre Francois Baclesse
Department Name
Oncology Department
Principal Investigator Name
Andreea Stephan
Principal Investigator Email
a.stefan@baclesse.unicancer.fr
Contact Person Name
Andreea Stephan
Contact Person Email
a.stefan@baclesse.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncology Department
Principal Investigator Name
Celeste Lebbé
Principal Investigator Email
celeste.lebbe@aphp.fr
Contact Person Name
Celeste Lebbé
Contact Person Email
celeste.lebbe@aphp.fr

Spain

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
08-04-2026
Processing Time Days
544
Number Of Sites
10
Number Of Participants
46

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Medical Oncology
Principal Investigator Name
Antonio Calles Blanco
Principal Investigator Email
antonio.calles@live.com
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Hospital Universitari Dexeus Grupo Quironsalud
Department Name
Oncology Department
Principal Investigator Name
María González Cao
Principal Investigator Email
mgonzalezcao@oncorosell.com
Contact Person Name
María González Cao
Contact Person Email
mgonzalezcao@oncorosell.com
Site Name
Complejo Hospitalario Universitario Insular Materno Infantil
Department Name
Medical Oncology
Principal Investigator Name
Delvys Rodríguez Abreu
Principal Investigator Email
drodabr@gobiernodecanarias.org
Contact Person Name
Delvys Rodríguez Abreu
Contact Person Email
drodabr@gobiernodecanarias.org
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Oncology Department
Principal Investigator Name
Valentina Boni
Principal Investigator Email
vboni@nextoncology.eu
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Clinic De Barcelona
Department Name
Oncology Department
Principal Investigator Name
Ana María Arance Fernández
Principal Investigator Email
AMARANCE@clinic.cat
Contact Person Name
Ana María Arance Fernández
Contact Person Email
AMARANCE@clinic.cat
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncology Department
Principal Investigator Name
Miguel Ángel Berciano Guerrero
Principal Investigator Email
migueberci@gmail.com
Contact Person Name
Miguel Ángel Berciano Guerrero
Contact Person Email
migueberci@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Principal Investigator Name
Valentina Gambardella
Principal Investigator Email
valen.gambardella@gmail.com
Contact Person Name
Valentina Gambardella
Contact Person Email
valen.gambardella@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncology Department
Principal Investigator Name
De la Cruz Merino Luis
Principal Investigator Email
luis.cruz.sspa@juntadeandalucia.es
Contact Person Name
De la Cruz Merino Luis
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Oncology Department
Principal Investigator Name
Irene Moreno Candilejo
Principal Investigator Email
irene.moreno@startmadrid.com
Contact Person Name
Irene Moreno Candilejo
Contact Person Email
irene.moreno@startmadrid.com
Site Name
Hospital General Universitario De Valencia
Department Name
Oncology Department
Principal Investigator Name
Alfonso Berrocal Jaime
Principal Investigator Email
berrocal.alf@gmail.com
Contact Person Name
Alfonso Berrocal Jaime
Contact Person Email
berrocal.alf@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
21-02-2025
Latest Decision Or Authorization Date
18-09-2025
Processing Time Days
209
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Medical Oncology
Principal Investigator Name
Paolo A. Ascierto
Principal Investigator Email
p.ascierto@istitutotumori.na.it
Contact Person Name
Paolo A. Ascierto
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
Medical Oncology
Principal Investigator Name
Matteo Duca
Principal Investigator Email
matteo.duca@istitutotumori.mi.it
Contact Person Name
Matteo Duca

Germany

Earliest CTIS Part Ii Submission Date
15-12-2025
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
7
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Elbe Kliniken Stade-Buxtehude gGmbH
Department Name
Dermatology
Principal Investigator Name
Peter Mohr
Principal Investigator Email
peter.mohr@elbekliniken.de
Contact Person Name
Peter Mohr
Contact Person Email
peter.mohr@elbekliniken.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Dermatology
Principal Investigator Name
Dirk Schadendorf
Principal Investigator Email
dirk.schadendorf@uk-essen.de
Contact Person Name
Dirk Schadendorf
Contact Person Email
dirk.schadendorf@uk-essen.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Dermatology
Principal Investigator Name
Christoffer Gebhardt
Principal Investigator Email
ch.gebhardt@uke.de
Contact Person Name
Christoffer Gebhardt
Contact Person Email
ch.gebhardt@uke.de

Sponsor

Primary sponsor

Full Name
Pierre Fabre Medicament
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Investigational products

Investigational Product Name
KIN-2787
Modality
Small molecule
Routes Of Administration
oral
Route
oral

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