A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)
Status: Recruiting
Location: See all (74) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ All Patients (unless otherwise noted):
• ≥ 18 years of age
• ECOG PS is 0 to 1
• Adequate organ function as outlined by the study
• Received prior standard therapy appropriate for tumor type and stage
• Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)
• Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)
• Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)
Locations
United States
Arizona
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
California
City of Hope - Duarte
RECRUITING
Duarte
City of Hope - Lennar
RECRUITING
Irvine
UC Davis, Davis Comprehensive Cancer Center
RECRUITING
Sacramento
University of California, San Diego Moores Cancer Center
RECRUITING
San Diego
UCSF Medical Center - Mission Bay
RECRUITING
San Francisco
Stanford University - Stanford Cancer Institute
RECRUITING
Stanford
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Boca Raton Clinical Research Associates
RECRUITING
Plantation
Cancer Specialists of North Florida
RECRUITING
Saint Augustine
H Lee Moffitt Cancer Center and Research Institute
RECRUITING
Tampa
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion)
RECRUITING
Detroit
Montana
Intermountain Health - St. Vincent Frontier Cancer Center
RECRUITING
Billings
Nebraska
Nebraska Cancer Specialist
RECRUITING
Grand Island
New York
Columbia University Medical Center
RECRUITING
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
New York University Langone Health
RECRUITING
New York
Clinical Research Alliance
RECRUITING
Westbury
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Pennsylvania
UPMC Hillman Cancer Center
RECRUITING
Pittsburgh
Tennessee
Baptist Medical Center
RECRUITING
Memphis
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
NEXT Oncology Dallas
RECRUITING
Irving
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Other Locations
Australia
Linear Clinical Research
RECRUITING
Nedlands
Denmark
Odense University Hospital, Department of Oncology
RECRUITING
Odense
France
EDOG - Institut Bergonié
RECRUITING
Bordeaux
Ambroise-Paré Hospital
RECRUITING
Boulogne
Hospices Civils de Lyon - Hôpital Louis Pradel
RECRUITING
Bron
Centre François Baclesse
RECRUITING
Caen
Centre Georges François Leclerc
RECRUITING
Dijon
CHU de Lille Institut Cœur Poumon
RECRUITING
Lille
CHU de Nantes
RECRUITING
Nantes
Institut Curie
RECRUITING
Paris
Hopital Foch
RECRUITING
Suresnes
Oncopole Claudius Regaud
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Germany
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte
RECRUITING
Berlin
Uniklinik Köln
RECRUITING
Cologne
Universitätsklinikum Carl Gustav Carus an der TU Dresden
RECRUITING
Dresden
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt Am Main
Thoraxklinik Heidelberg gGmbH - Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Krankenhaus Bethanien Moers
RECRUITING
Moers
Greece
Henry Dunant Hospital Center
RECRUITING
Athens
Thoracic General Hospital of Athens I SOTIRIA
RECRUITING
Athens
Italy
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l
RECRUITING
Meldola
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei tumori
RECRUITING
Milan
A.O.U. San Luigi Gonzaga-Orbassano - SCDU Oncologia Medica
RECRUITING
Orbassano
Ospedale Santa Maria Delle Croci
RECRUITING
Ravenna
Fondazione Policlinico Universitario A Gemelli-Rome
RECRUITING
Rome
IRCCS Instituto Nazionale tumori Ragina Elena
RECRUITING
Rome
Netherlands
The Netherlands Cancer Institute (NKI)
RECRUITING
Amsterdam
University Medical Centre Groningen
RECRUITING
Groningen
Leiden University Medical Center
RECRUITING
Leiden
University Medical Center Utrecht
RECRUITING
Utrecht
Spain
Complejo Hospitalario Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitari Vall D' Hebron
RECRUITING
Barcelona
ICO Badalona - H.U. Germans Trias i Pujol
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Regional Universitario de Malaga - Hospital Civil
RECRUITING
Málaga
Clinica Universidad de Navarra
RECRUITING
Pamplona
Hospital Universitario Virgen del Rocio - PPDS
RECRUITING
Seville
Fundacion Instituto Valenciano de Oncologia
RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Chi Mei Hospital, Liouying
RECRUITING
Tainan
Taipei Municipal Wanfang Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Revolution Medicines
medinfo@RevMed.com
1-844-2-REVMED
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2028-12
Participants
Target number of participants: 616
Treatments
Experimental: Subprotocol A: KRAS G12C-Mutated Solid Tumors
RMC-6291 (BID), RMC-6236 (QD), and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W)
Experimental: Subprotocol B: RAS-mutated NSCLC
RMC-6236 (QD) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W)
Experimental: Subprotocol C: RAS G12D-mutated NSCLC
RMC-9805 (QD or BID), RMC-6236 (QD), and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W).
Experimental: Subprotocol D: RAS G12D-mutated NSCLC
RMC-9805 (QD)
Related Therapeutic Areas
Sponsors
Leads: Revolution Medicines, Inc.