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New pill targets Hard-to-Treat cancers in early trial

NCT ID NCT05462717

Disease control Sponsor: Revolution Medicines, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new drug called RMC-6291 in adults with advanced cancers (lung, colon, pancreatic) that have a specific KRAS G12C mutation. The goal is to find the safest dose and see how well the drug works. About 222 participants will receive the drug by mouth, and researchers will monitor side effects and drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 222 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Primary central nervous system (CNS) tumors * 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 Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

appendiceal neoplasm bronchial neoplasm colonic neoplasm colorectal cancer colorectal neoplasm digestive system neoplasm endometrium neoplasm Esophageal Neoplasms gastric neoplasm intestinal cancer lung disorder lung neoplasm neoplasm Neoplasm Metastasis Neoplasms by Site non-small cell lung carcinoma ovarian cancer pancreatic ductal adenocarcinoma pancreatic neoplasm rectal neoplasm respiratory system disorder respiratory tract neoplasm Thoracic Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Colorectal cancer (CRC) Non-small cell lung cancer (NSCLC) Pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • American Oncology Partners of Maryland

    Bethesda, Maryland, 20817, United States

  • Austin Health, Olivia Newton-John Cancer Research & Wellness Centre

    Heidelberg, Victoria, 3084, Australia

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, 10043, Italy

  • CHU Bordeaux Hospital Saint-Andre

    Bordeaux, 33000, France

  • CHU Nantes

    Nantes, 44093, France

  • Centre Jean Perrin

    Clermont-Ferrand, 63011, France

  • Centre Léon Bérard

    Lyon, 69008, France

  • Centre Oscar Lambret

    Lille, 59000, France

  • Centro Ricerche Cliniche di Verona s.r.l.

    Verona, 37134, Italy

  • Chiang Mai University

    Chiang Mai, 50200, Thailand

  • Clinica Universidad de Navarra

    Pamplona, 31008, Spain

  • Clinical hospital center Bezanijska Kosa

    Belgrade, 11071, Serbia

  • Clínica Universidad de Navarra

    Madrid, 28027, Spain

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • E-DA hospital

    Kaohsiung City, Yanchao District, 82445, Taiwan

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100, Italy

  • Highlands Oncology Group

    Springdale, Arkansas, 72762, United States

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Quirónsalud

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • ICANS

    Strasbourg, 67200, France

  • ICO

    Angers, 49055, France

  • ICO Hospitalet

    Barcelona, 08908, Spain

  • Institute for pulmonary diseases Sremska Kamenica

    Kamenitz, 21204, Serbia

  • Instytut MSF Sp zoo

    Lodz, 90-302, Poland

  • Istituto Europeo Oncologico

    Milan, 20141, Italy

  • Istituto Nazionale Tumori Fondazione G. Pascale

    Naples, 80131, Italy

  • Khon Kaen University

    Khon Kaen, 40002, Thailand

  • Klinika onkologie a radioterapie, Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005, Czechia

  • Korea University Hospital

    Seoul, 02708, South Korea

  • MD Anderson Cancer Center

    Madrid, 28033, Spain

  • MSB General Hospital

    Belgrade, 11000, Serbia

  • MSK Cancer Center

    New York, New York, 10021, United States

  • Med - Polonia Sp. z o. o.

    Poznan, 60-693, Poland

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NEXT Oncology IOB Hospital Quirónsalud

    Barcelona, 08023, Spain

  • NH Hospital a.s.

    Hořovice, 268 31, Czechia

  • Narodowy Instytut Onkologii

    Warsaw, 02-781, Poland

  • National Cancer centre Singapore

    Singapore, 168583, Singapore

  • National Cheng Kung University Hospital

    Tainan, 70457, Taiwan

  • National Taiwan University Hospital

    Taipei, 10048, Taiwan

  • Next Oncology

    San Antonio, Texas, 78229, United States

  • Next Oncology Virginia

    Fairfax, Virginia, 22031, United States

  • Onkologicka klinika, Fakultni Nemocnice Olomouc

    Olomouc, 77900, Czechia

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199, Australia

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14203, United States

  • S.C. Oncologia Falck, Dipartimento Ematologia ed Oncologia Niguarda Cancer Center

    Milan, 20162, Italy

  • START

    San Antonio, Texas, 78229, United States

  • Sarawak General Hospital

    Kuching, 93586, Malaysia

  • Seoul National University Hospital

    Seoul, 3080, South Korea

  • Severance Hospital

    Seoul, 3722, South Korea

  • Siriraj Hospital

    Bangkok Noi, 10700, Thailand

  • South West Health Care

    Warrnambool, Victoria, 3280, Australia

  • Southside Cancer Care Centre

    Sydney, New South Wales, 2228, Australia

  • Taipei Tzu Chi Hospital

    New Taipei City, 231, Taiwan

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • UC Davis Cancer Center

    Sacramento, California, 95817, United States

  • UC Irvine Cancer Center

    Orange, California, 92868, United States

  • UCSF

    San Francisco, California, 94158, United States

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University of Miami School of Medicine Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136, United States

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