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NCT05462717Active, not recruitingPhase 1

Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Phase 1/1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors

Source: ClinicalTrials.gov · Last updated 15 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
222 (estimated)
First submitted
11 Jul 2022
Start date
19 Sept 2022
Primary completion date
31 Mar 2027
Lead sponsor
Revolution Medicines, Inc.
NCT number
NCT05462717
EU CT number
2024-511548-19-00
EudraCT number
2022-000388-35

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 222
  • From 19 Sept 2022 to the primary completion date, 31 Mar 2027
  • 63 sites in 13 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
  • Prior therapy with KRASG12C (ON) inhibitor
    • Other inclusion/exclusion criteria may apply.

Other illness

  • Known impairment of GI function that would alter the absorption

Other

  • Primary central nervous system (CNS) tumors
  • Active brain metastases

Who the study is looking for

  • Subject must be ≥18 years of age.
  • 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 and for NSCLC in dose expansion
  • Adequate organ function

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peninsula & South Eastern Haematology and Oncology Group
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FrankstonAustraliaUnknown status
Austin Health, Olivia Newton-John Cancer Research & Wellness Centre
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HeidelbergAustraliaUnknown status
Southside Cancer Care Centre
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SydneyAustraliaUnknown status
South West Health Care
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WarrnamboolAustraliaUnknown status
Multiscan s.r.o.
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HořoviceCzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
University Hospital Olomouc
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OlomoucCzechiaActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Quirónsalud Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
MD Anderson Cancer Center
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MadridSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainActive, not recruiting
Institut de Cancerologie de L'Ouest
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AngersFranceActive, not recruiting
CHU De Bordeauxt
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Bordeaux CedexFranceActive, not recruiting
Centre Jean Perrin
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Clermont-FerrandFranceActive, not recruiting
Centre Oscar Lambret
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LilleFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg Cedex 2FranceActive, not recruiting
European Institute Of Oncology S.r.l.
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MilanItalyActive, not recruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyActive, not recruiting
Centro Ricerche Cliniche di Verona s.r.l.
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VeronaItalyActive, not recruiting
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Korea University Hospital
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Sarawak General Hospital
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KuchingMalaysiaUnknown status
Instytut MSF Sp. z o.o.
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LodzPolandCompleted
Med Polonia Sp z o.o.
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PoznanPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandCompleted
MSB General Hospital
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BelgradeSerbiaUnknown status
Clinical hospital center Bezanijska Kosa
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BelgradeSerbiaUnknown status
Institute for pulmonary diseases Sremska Kamenica
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KamenitzSerbiaUnknown status
National Cancer Centre Singapore
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SingaporeSingaporeUnknown status
Siriraj Hospital
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Bangkok NoiThailandUnknown status
Chiang Mai University
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Chiang MaiThailandUnknown status
Khon Kaen University
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Khon KaenThailandUnknown status
E-DA Hospital
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Kaohsiung CityTaiwanUnknown status
Taipei Tzu Chi Hospital
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New Taipei CityTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
American Oncology Partners of Maryland
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BethesdaUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Roswell Park Comprehensive Cancer Center
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BuffaloUnited StatesUnknown status
NEXT Oncology- Virginia
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FairfaxUnited StatesUnknown status
University of Miami School of Medicine Sylvester Comprehensive Cancer Center
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MiamiUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
MSK Cancer Center
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New YorkUnited StatesUnknown status
Columbia University Irving Medical Center
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New YorkUnited StatesUnknown status
UC Irvine Cancer Center
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OrangeUnited StatesUnknown status
UC Davis Cancer Center
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SacramentoUnited StatesUnknown status
START
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San AntonioUnited StatesUnknown status
NEXT Oncology
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San AntonioUnited StatesUnknown status
UCSF
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San FranciscoUnited StatesUnknown status
Highlands Oncology Group
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SpringdaleUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.