Clinical trial • Phase III • Oncology

RMC-6291 for Non-small cell lung cancer | Pancreatic adenocarcinoma | Colorectal cancer

Phase III trial of RMC-6291 for Non-small cell lung cancer | Pancreatic adenocarcinoma | Colorectal cancer. 100 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Non-small cell lung cancer | Pancreatic adenocarcinoma | Colorectal cancer
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
19-02-2024
First CTIS Authorization Date
10-06-2024

Trial design

Phase III trial across 32 sites in Italy, Germany, Netherlands and others.

Biomarker Stratified
True - KRASG12C mutation (enrolment biomarker)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
100

Eligibility

Recruits 100 Vulnerable population selected; no details provided on consent or assent handling..

Vulnerable Population
Vulnerable population selected; no details provided on consent or assent handling.

Recruitment

Planned Sample Size
100
Recruitment Window Months
31

Geography

Total Number Of Sites
32
Total Number Of Participants
110

Italy

Earliest CTIS Part Ii Submission Date
27-05-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
575
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Department Name
Melanoma, Cancer Immunotherapy and Development Therapeutics
Contact Person Name
Paolo Antonio Ascierto
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncology
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medical Oncology
Contact Person Name
Rossana Berardi
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Medical Oncology
Contact Person Name
Alessandra Bearz
Contact Person Email
a.bearz@cro.it
Site Name
Azienda Ospedaliero Universitaria Parma
Department Name
Medical Oncology
Contact Person Name
Marcello Tiseo
Contact Person Email
mtiseo@ao.pr.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Medical Oncology
Contact Person Name
Alessio Amatu
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Oncohematological
Contact Person Name
Manolo D'Arcangelo
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Simple Departmental Structure of Thoracic Oncology
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it

Germany

Earliest CTIS Part Ii Submission Date
27-05-2024
Latest Decision Or Authorization Date
05-01-2026
Processing Time Days
588
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers
Department Name
Klinik für Lungen- & Bronchialheilkunde
Contact Person Name
Karl-Otto Kambartel
Contact Person Email
Kambartel@bethanienmoers.de
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling
Site Name
Klinikum Nuernberg
Department Name
Hematology and Medical Oncology
Contact Person Name
Stefan Knop
Site Name
University Hospital Cologne AöR
Department Name
Internal Medicine/ Center for Integrated Oncology
Contact Person Name
Jürgen Wolf
Contact Person Email
juergen.wolf@uk-koeln.de

Netherlands

Earliest CTIS Part Ii Submission Date
27-05-2024
Latest Decision Or Authorization Date
22-12-2025
Processing Time Days
574
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Medical Oncology
Contact Person Name
Frans Opdam
Contact Person Email
f.opdam@nki.nl

Spain

Earliest CTIS Part Ii Submission Date
16-05-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
586
Number Of Sites
11
Number Of Participants
20

Sites

Site Name
MD Anderson Cancer Center
Department Name
Oncology
Contact Person Name
Fernando Fabio Franco
Contact Person Email
ffranco@fundacionmdanderson.es
Site Name
Clinica Universidad De Navarra
Department Name
Medical Oncology
Contact Person Name
Mariano Ponz-Sarvise
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Medical Oncology
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncology
Contact Person Name
Luis Paz-Ares
Contact Person Email
lpazares@hotmail.com
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Medical Oncology
Contact Person Name
Angel Artal
Contact Person Email
aartalc@salud.aragon.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncology
Contact Person Name
Francisco de Asis Aparisi Aparisi
Contact Person Email
francisco_aparisi@iislafe.es
Site Name
Hospital Hm Nou Delfos
Department Name
Oncology
Contact Person Name
Tatiana Hernandez Guerrero
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncology
Contact Person Name
Bernard Doger
Contact Person Email
Bernard.doger@startmadrid.com
Site Name
Institut Catala D'oncologia
Department Name
Oncology
Contact Person Name
Jose Carlos Ruffinelli Rodriguez
Contact Person Email
jruffinelli@iconcologia.net
Site Name
Clinica Universidad De Navarra (Madrid site)
Department Name
Medical Oncology
Contact Person Name
Mariano Ponz-Sarvise
Contact Person Email
mponz@unav.es
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Medical Oncology
Contact Person Name
David Vincente Baz
Contact Person Email
dvicentebaz@yahoo.es

France

Earliest CTIS Part Ii Submission Date
14-03-2024
Latest Decision Or Authorization Date
23-12-2025
Processing Time Days
649
Number Of Sites
8
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology Medical Department
Contact Person Name
Elvire Pons-Tostivint
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology Department
Contact Person Name
Frederic Bigot
Site Name
Centre Leon Berard
Department Name
Medical Oncology
Contact Person Name
Loic Verlingue
Site Name
Institut Bergonie
Department Name
Medical Oncology
Contact Person Name
Sophie Cousin
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Centre Oscar Lambret
Department Name
Medical Oncology
Contact Person Name
Loïc Lebellec
Contact Person Email
l-lebellec@o-lambret.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Medical Oncology
Contact Person Name
Lauriane Eberst
Contact Person Email
l.eberst@icans.eu
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical Oncology
Contact Person Name
Diego Tosi
Contact Person Email
Diego.Tosi@icm.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
Pulmonology
Contact Person Name
Michael Duruisseaux

Sponsor

Primary sponsor

Full Name
Revolution Medicines Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
RMC-6291
Investigational Product Name
RMC-6236
Combination Treatment
Yes

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