Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients with Advanced KRAS G12C-mutated Solid Tumors

Start 10 Jul 2024 · Status Ongoing, recruiting · 5 EU/EEA countries · 33 sites · Protocol RMC-6291-101

Overview

Sponsor-declared trial summary

Phase Phase I and Phase II (Integrated) - Other

Status Ongoing, recruiting

Participants planned 534

Countries 5

Sites 33

Participants with Advanced KRASG12C-Mutated Solid Tumors

Key facts

Sponsor: Revolution Medicines Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Neoplasms [C04]
Trial duration: 10 Jul 2024 → ongoing
Decision date (initial): 2024-06-17
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

External identifiers

EU CT number: 2023-508178-27-00
ClinicalTrials.gov: NCT06128551

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Participants with Advanced KRASG12C-Mutated Solid Tumors

Version	Level	Code	Term	System organ class
21.0	PT	10061451	Colorectal cancer	100000004864
21.1	LLT	10051971	Pancreatic adenocarcinoma	10029104
21.1	PT	10061873	Non-small cell lung cancer	100000004864

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Revolution Medicines Inc.

Sponsor organisation: Revolution Medicines Inc.
Address: 700 Saginaw Drive
City: Redwood City
Postcode: 94063-4752
Country: United States

Scientific contact point

Organisation: Revolution Medicines Inc.
Contact name: Justin Meyerowitz

Public contact point

Organisation: Revolution Medicines Inc.
Contact name: Justin Meyerowitz

Locations

5 EU/EEA countries · 33 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Ongoing, recruiting	100	8
Germany	Ongoing, recruiting	40	4
Italy	Ongoing, recruiting	50	9
Netherlands	Ongoing, recruiting	50	1
Spain	Ongoing, recruiting	60	11
Rest of world United States	—	234	—

Investigational sites

France

8 sites · Ongoing, recruiting

Hospices Civils De Lyon

Pulmonology, 59 Boulevard Pinel, 69500, Bron

Institut De Cancerologie Strasbourg Europe

Medical Oncology, 17 Rue Albert Calmette, 67200, Strasbourg

Centre Hospitalier Universitaire De Nantes

Oncology Medical Department, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1

Centre Oscar Lambret

Medical Oncology, 3 Rue Frederic Combemale, 59000, Lille

Institut Bergonie

Medical Oncology, 229 Cours De L Argonne, 33000, Bordeaux

Centre Leon Berard

Medical Oncology, 28 Rue Laennec, 69008, Lyon

Institut De Cancerologie De L Ouest

Oncology Department, 15 Rue Andre Boquel, 49100, Angers

Institut Regional Du Cancer De Montpellier

Medical Oncology, 208 Avenue Des Apothicaires, 34298, Montpellier Cedex 5

Germany

4 sites · Ongoing, recruiting

Stiftung Krankenhaus Bethanien Fuer Die Grafschaft Moers

Klinik für Lungen- & Bronchialheilkunde, Bethanienstrasse 21, Innenstadt, Moers

Klinikum Nuernberg

Hematology and Medical Oncology, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg

Klinikum Esslingen GmbH

Klinik für Kardiologie, Angiologie und Pneumologie, Hirschlandstrasse 97, Oberesslingen, Esslingen Am Neckar

University Hospital Cologne AöR

Internal Medicine/ Center for Integrated Oncology, Kerpener Strasse 62, Lindenthal, Cologne

Italy

9 sites · Ongoing, recruiting

Azienda Ospedaliero Universitaria Delle Marche

Medical Oncology, Via Conca 71, 60126, Ancona

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Simple Departmental Structure of Thoracic Oncology, Via Piero Maroncelli 40, 47014, Meldola

Azienda Ospedaliero-Universitaria San Luigi Gonzaga

Oncology, Regione Gonzole 10, 10043, Orbassano

ASST Grande Ospedale Metropolitano Niguarda

Medical Oncology, Piazza Dell'ospedale Maggiore 3, 20162, Milan

Azienda Unita Sanitaria Locale Della Romagna

Oncohematological, Viale Vincenzo Randi 5, 48121, Ravenna

Centro Ricerche Cliniche Di Verona S.r.l.

Oncology, Piazzale Ludovico Antonio Scuro 10, 37134, Verona

Centro Di Riferimento Oncologico Di Aviano

Medical Oncology, Via Franco Gallini 2, 33081, Aviano

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Melanoma, Cancer Immunotherapy and Development Therapeutics, Via Mariano Semmola 52, 80131, Naples

Azienda Ospedaliero Universitaria Parma

Medical Oncology, Viale Antonio Gramsci 14, 43126, Parma

Netherlands

1 site · Ongoing, recruiting

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Medical Oncology, Plesmanlaan 121, 1066 CX, Amsterdam

Spain

11 sites · Ongoing, recruiting

Hospital Universitario Virgen De La Macarena

Medical Oncology, Avenida Del Doctor Fedriani 3, 41009, Sevilla

Hospital Universitario Y Politecnico La Fe

Oncology, Avenida De Fernando Abril Martorell 106, 46026, Valencia

Hospital Hm Nou Delfos

Oncology, Avinguda De Vallcarca 151, 08023, Barcelona

Hospital Unviersitario Miguel Servet

Medical Oncology, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza

Clinica Universidad De Navarra

Medical Oncology, Calle Marquesado De Santa Marta 1, 28027, Madrid

Hospital Universitario Fundacion Jimenez Diaz

Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid

Hospital Universitario Quironsalud Madrid

Medical Oncology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon

MD Anderson Cancer Center

Oncology, Calle De Arturo Soria Nº 270, 28033, Madrid

Hospital Universitario 12 De Octubre

Medical Oncology, Bloque D, Avenida De Cordoba Sn, Madrid

Institut Catala D'oncologia

Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat