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Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Sponsor: Revolution Medicines, Inc.
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of escalating doses of RMC-6291 (KRAS G12C(ON) inhibitor) monotherapy in adult subjects with advanced solid tumors and to identify the maximum tolerated dose (MTD), and the recommended Phase 2 dose.
Official title: Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2022-09-19
Completion Date
2027-09-30
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Interventions
RMC-6291
Oral tablet once or twice a day
Locations (64)
Highlands Oncology Group
Springdale, Arkansas, United States
UC Irvine Cancer Center
Orange, California, United States
UC Davis Cancer Center
Sacramento, California, United States
UCSF
San Francisco, California, United States
University of Miami School of Medicine Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
American Oncology Partners of Maryland
Bethesda, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
MSK Cancer Center
New York, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
Next Oncology
San Antonio, Texas, United States
START
San Antonio, Texas, United States
Next Oncology Virginia
Fairfax, Virginia, United States
Southside Cancer Care Centre
Sydney, New South Wales, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
Heidelberg, Victoria, Australia
South West Health Care
Warrnambool, Victoria, Australia
NH Hospital a.s.
Hořovice, Czechia
Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Onkologicka klinika, Fakultni Nemocnice Olomouc
Olomouc, Czechia
ICO
Angers, France
CHU Bordeaux Hospital Saint-Andre
Bordeaux, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
CHU Nantes
Nantes, France
ICANS
Strasbourg, France
S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center
Milan, Italy
Istituto Europeo Oncologico
Milan, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, Italy
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Sarawak General Hospital
Kuching, Malaysia
Instytut MSF Sp zoo
Lodz, Poland
Med - Polonia Sp. z o. o.
Poznan, Poland
Narodowy Instytut Onkologii
Warsaw, Poland
MSB General Hospital
Belgrade, Serbia
Clinical hospital center Bezanijska Kosa
Belgrade, Serbia
Institute for pulmonary diseases Sremska Kamenica
Kamenitz, Serbia
National Cancer centre Singapore
Singapore, Singapore
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Korea University Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
NEXT Oncology IOB Hospital Quirónsalud
Barcelona, Spain
ICO Hospitalet
Barcelona, Spain
Clínica Universidad de Navarra
Madrid, Spain
MD Anderson Cancer Center
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Universitario Quirónsalud
Pozuelo de Alarcón, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
E-DA hospital
Kaohsiung City, Yanchao District, Taiwan
Taipei Tzu Chi Hospital
New Taipei City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Siriraj Hospital
Bangkok Noi, Thailand
Chiang Mai University
Chiang Mai, Thailand
Khon Kaen University
Khon Kaen, Thailand