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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT04185883

Disease control Sponsor: Amgen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a drug called sotorasib, alone or with other cancer treatments, in adults with advanced solid tumors that have a specific KRAS G12C mutation. The main goals are to check safety and how the body handles the drug. About 610 participants are enrolled across multiple treatment groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotorasib (a targeted cancer drug) alone or combined with other anti-cancer drugs
What this could lead to
If successful, this could lead to new treatment options for people with advanced solid tumors that have a specific KRAS mutation.
What could go wrong
This is an early-phase trial focused on safety, so it is not yet known if the drug works well. Side effects are possible, and the results may not apply to all patients.

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

610 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Dec 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 to 100 years

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: * Men or women greater than or equal to 18 years old. * Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory. Exclusion Criteria: * Primary brain tumor. * Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors. * Myocardial infarction within 6 months of study day 1. * Gastrointestinal (GI) tract disease causing the inability to take oral medication.

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

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

Advanced solid tumors Kirsten rat sarcoma (KRAS) PG12C mutation

Contacts and locations

Locations

  • Aichi Cancer Center

    Nagoya, Aichi-ken, 464-8681, Japan

  • Arizona Oncology Associates Professional Corporation

    Tucson, Arizona, 85711, United States

  • Asan Medical Center

    Seoul, 138-736, South Korea

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57108, United States

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec, Quebec, G1J 1Z4, Canada

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    Verona, 37126, Italy

  • Charite Universitaetsmedizin Berlin, Campus Virchow

    Berlin, 13353, Germany

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    New York, New York, 10032, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • GenesisCare -North Shore Oncology

    St Leonards, New South Wales, 2065, Australia

  • Gibbs Cancer Center and Research Institute - Spartanburg

    Spartanburg, South Carolina, 29303, United States

  • Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)

    Detroit, Michigan, 48202, United States

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland, 4101, Australia

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Catalonia, 08908, Spain

  • Johns Hopkins University

    Baltimore, Maryland, 21224, United States

  • Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305, Taiwan

  • Loma Linda University Cancer Center

    Loma Linda, California, 92354, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Medizinische Universitaet Graz

    Graz, 8036, Austria

  • Memorial Cancer Institute

    Pembroke Pines, Florida, 33028, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Nepean Cancer Centre

    Kingswood, New South Wales, 2747, Australia

  • Northwest Cancer Specialists - Vancouver

    Vancouver, Washington, 98684, United States

  • Northwest Medical Specialties, PLLC

    Tacoma, Washington, 98405, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Norwalk Hospital

    Norwalk, Connecticut, 06856, United States

  • Oncology Consultants

    Houston, Texas, 77030, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Rocky Mountain Cancer Centers Denver Midtown

    Denver, Colorado, 80218, United States

  • Roswell Park Cancer Institute

    Buffalo, New York, 32224, United States

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute UK

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • St John of God Healthcare

    Subiaco, Western Australia, 6008, Australia

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Texas Oncology Central-South

    Austin, Texas, 78705, United States

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702, United States

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591, South Korea

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • US Oncology Research Investigational Products Center

    The Woodlands, Texas, 77380, United States

  • United States Oncology Regulatory Affairs Corporate Office

    Nashville, Tennessee, 37203, United States

  • Universitaetsklinikum Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • Universitatsklinikum Koln

    Cologne, 50937, Germany

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200, Belgium

  • University of California Davis Medical Center

    Sacramento, California, 95817, United States

  • University of California Los Angeles

    Santa Monica, California, 90404, United States

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • University of California San Francisco Mission Bay Campus

    San Francisco, California, 94115, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109-5912, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19111, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Southern California, Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031, United States

  • Washington University

    St Louis, Missouri, 63110-1093, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520, United States

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