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New pill targets Hard-to-Treat KRAS cancers in first human trial

NCT ID NCT07094113

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 4 times

Summary

This early-stage trial tests a new oral drug called AMG 410, alone or with other medicines, in adults with advanced solid tumors that have KRAS gene changes. The study aims to find a safe dose and check for side effects. About 434 participants will take part across multiple dose levels.

What this could mean

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

Active substance
AMG 410 (oral tablet), pembrolizumab (IV infusion), panitumumab (IV infusion)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have KRAS mutations, especially those who have run out of standard therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or may cause serious side effects. The study is primarily looking at safety and dosing, not yet proving effectiveness.

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 434 people

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

Started

Jul 2025

Expected to finish

Apr 2031

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: 1. Age ≥ 18 years (or \> legal age within the country if it is older than 18 years). 2. Pathologically documented, locally-advanced or metastatic malignancy with any missense mutation in the KRAS gene or evidence of KRAS amplification using an analytically validated KRASWT amplification assay. 3. Participants must have no standard of care treatment options or have actively refused such therapy. 4. Able to swallow and retain per oral administered study treatment. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), as determined by the site investigator. 7. Adequate organ function. 8. Archival (formalin-fixed, paraffin-embedded \[FFPE\]) tumor tissue or block collected within 5 years before screening must be available. Participants without archived tumor tissue may undergo tumor biopsy before AMG 410 dosing (Day1). Exclusion Criteria: 1. Untreated symptomatic central nervous system or leptomeningeal metastases. 2. Uncontrolled pleural effusion and/or ascites. 3. History of other malignancy within the past 5 years. 4. Active systemic infection or symptoms that indicate an acute and/or uncontrolled infection requiring IV antibiotics within 7days prior to the first dose of study treatment. 5. History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis). 6. Live and live-attenuated vaccines are prohibited within 28 days prior to the first dose of study treatment. 7. History of solid organ transplant. 8. Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy, or investigational agent) within 28 days of first dose of study treatment. 9. Presence or history of any of the following viral infections: HIV, Hepatitis C, Hepatitis B, and active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 10. Toxicities from prior anti-tumor therapy (including radiotherapy) not having improved to at least Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1. 11. Therapeutic or palliative radiation therapy within 2 weeks of first dose of study treatment. 12. Major surgery within 28 days of first dose of study treatment. 13. History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to participant safety.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

KRAS altered advanced or metastatic solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    39 sites in 14 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aichi Cancer Center

    RECRUITING

    Nagoya, Aichi-ken, 464-8681, Japan

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Centro Ricerche Cliniche Di Verona Societa responsabilita limitata

    RECRUITING

    Verona, 37134, Italy

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400044, China

  • Chris OBrien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Hospital Universitari Vall d Hebron

    RECRUITING

    Barcelona, Catalonia, 08023, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, 250013, China

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa-shi, Chiba, 277-8577, Japan

  • Next Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Next Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 1Z5, Canada

  • Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Sarah Cannon Research Institute Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Sir Mortimer B Davis - Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Siteman Cancer Center - Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • The Queen Elizabeth Hospital

    RECRUITING

    Woodville South, South Australia, 5011, Australia

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Universitaetsklinikum Essen

    RECRUITING

    Essen, 45147, Germany

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States