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New pill targets hard-to-treat cancers with KRAS G12D mutation

NCT ID NCT06179160

Disease control Sponsor: Incyte Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 23, 2026 · Updated 2 times

Summary

This early-phase study tests a new drug called INCB161734, alone or with other cancer treatments, in people with advanced solid tumors that have a specific KRAS G12D mutation. The main goals are to check safety and find the right dose. About 710 adults whose cancer has worsened after standard treatments may join.

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 710 people

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

Started

Jan 2024

Expected to finish

Jan 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: * ≥18 years old. * Locally advanced or metastatic solid tumor with KRAS G12D mutation. * For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome. * Cohort specific requirements aas defined in the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Prior treatment with any KRAS G12D inhibitor * Known additional invasive malignancy within 1 year of the first dose of study drug * History of organ transplant, including allogeneic stem cell transplantation * Significant, uncontrolled medical condition * History or presence of an ECG abnormality * Inadequate organ function Other protocol-defined Inclusion/Exclusion Criteria may apply

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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.

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

    34 sites in 8 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Centre Leon Berard

    RECRUITING

    Lyon, 69373, France

  • Centro Ricerche Cliniche Di Verona

    RECRUITING

    Verona, 37134, Italy

  • Chris Obrien Lifehouse

    RECRUITING

    Camperdown, New South Wales, 02050, Australia

  • Cliniques Universitaires Ucl Saint-Luc

    RECRUITING

    Brussels, 01200, Belgium

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Fondazione Irccs Istituto Nazionale Dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Fundacion Jimenez Diaz

    RECRUITING

    Madrid, 28040, Spain

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Hospital General Universitario Vall D Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Quironsalud Madrid

    RECRUITING

    Madrid, 28223, Spain

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94805, France

  • Irccs Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20089, Italy

  • Jefferson University Hospitals

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, 06009, Australia

  • Mayo Clinic Hospital

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10022, United States

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, 277-0882, Japan

  • Peter Maccallum Cancer Centre

    RECRUITING

    Melbourne, Victoria, 03000, Australia

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Sarah Cannon Research Institue At Healthone

    RECRUITING

    Denver, Colorado, 80218, United States

  • Scri Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • St Vincent'S Hospital Sydney

    RECRUITING

    Darlinghurst, New South Wales, 02010, Australia

  • Stanford University

    RECRUITING

    Palo Alto, California, 94305, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 03004, Australia

  • The Cancer Institute Hospital of Jfcr

    RECRUITING

    Tokyo, 135-0063, Japan

  • The Ottawa Hospital Cancer Center

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • UCLA Healthcare Hematology-Oncology

    RECRUITING

    Santa Monica, California, 90404, United States

  • Universitair Ziekenhuis (Uz) Leuven

    RECRUITING

    Leuven, 03000, Belgium

  • Universitair Ziekenhuis Antwerpen (Uza)

    RECRUITING

    Edegem, 02650, Belgium

  • Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole

    RECRUITING

    Toulouse, 31059, France

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10021, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.