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.
- Diseases
- Endometrial cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- 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
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peninsula & South Eastern Haematology and Oncology Group Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Austin Health, Olivia Newton-John Cancer Research & Wellness Centre Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Southside Cancer Care Centre Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| South West Health Care Coordinator of this site? Confirm its status | Warrnambool | Australia | Unknown status |
| Multiscan s.r.o. Coordinator of this site? Confirm its status | Hořovice | Czechia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Quirónsalud Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Active, not recruiting |
| Institut de Cancerologie de L'Ouest Coordinator of this site? Confirm its status | Angers | France | Active, not recruiting |
| CHU De Bordeauxt Coordinator of this site? Confirm its status | Bordeaux Cedex | France | Active, not recruiting |
| Centre Jean Perrin Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Active, not recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| European Institute Of Oncology S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Centro Ricerche Cliniche di Verona s.r.l. Coordinator of this site? Confirm its status | Verona | Italy | Active, not recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Korea University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Sarawak General Hospital Coordinator of this site? Confirm its status | Kuching | Malaysia | Unknown status |
| Instytut MSF Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
| Med Polonia Sp z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| MSB General Hospital Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical hospital center Bezanijska Kosa Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Institute for pulmonary diseases Sremska Kamenica Coordinator of this site? Confirm its status | Kamenitz | Serbia | Unknown status |
| National Cancer Centre Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Siriraj Hospital Coordinator of this site? Confirm its status | Bangkok Noi | Thailand | Unknown status |
| Chiang Mai University Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Khon Kaen University Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Taipei Tzu Chi Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| American Oncology Partners of Maryland Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Roswell Park Comprehensive Cancer Center Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| NEXT Oncology- Virginia Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| University of Miami School of Medicine Sylvester Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Tennessee Oncology Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| MSK Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UC Irvine Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| UC Davis Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| START Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| NEXT Oncology Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Highlands Oncology Group Coordinator of this site? Confirm its status | Springdale | United States | Unknown status |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.