Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors
NCT ID: NCT05462717
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
222 participants
INTERVENTIONAL
2022-09-19
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RMC-6291
Dose Escalation and Dose Expansion
RMC-6291
Oral tablet once or twice a day
Interventions
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RMC-6291
Oral tablet once or twice a day
Eligibility Criteria
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Inclusion Criteria
* Subject must have pathologically documented, locally advanced or metastatic KRASG12C-mutated solid tumor malignancy (not amenable to curative surgery) that has previously been treated with standard-of-care therapies for respective tumor types, is intolerant to, or is considered ineligible for standard-of-care anticancer treatments.
* ECOG performance status 0 or 1
* Prior treatment with a KRASG12C (OFF) inhibitor allowed for dose escalation
* Adequate organ function
Exclusion Criteria
* Active brain metastases
* Known impairment of GI function that would alter the absorption
* Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
* Prior therapy with KRASG12C (ON) inhibitor
18 Years
ALL
No
Sponsors
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Revolution Medicines, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Revolution Medicines, Inc.
Role: STUDY_DIRECTOR
Revolution Medicines, Inc.
Locations
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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
Napoli, , 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 City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Siriraj Hospital
Bangkok Noi, , Thailand
Chiang Mai University
Chiang Mai, , Thailand
Khon Kaen University
Khon Kaen, , Thailand
Countries
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References
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Schulze CJ, Seamon KJ, Zhao Y, Yang YC, Cregg J, Kim D, Tomlinson A, Choy TJ, Wang Z, Sang B, Pourfarjam Y, Lucas J, Cuevas-Navarro A, Ayala-Santos C, Vides A, Li C, Marquez A, Zhong M, Vemulapalli V, Weller C, Gould A, Whalen DM, Salvador A, Milin A, Saldajeno-Concar M, Dinglasan N, Chen A, Evans J, Knox JE, Koltun ES, Singh M, Nichols R, Wildes D, Gill AL, Smith JAM, Lito P. Chemical remodeling of a cellular chaperone to target the active state of mutant KRAS. Science. 2023 Aug 18;381(6659):794-799. doi: 10.1126/science.adg9652. Epub 2023 Aug 17.
Other Identifiers
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RMC-6291-001
Identifier Type: -
Identifier Source: org_study_id
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