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

NCT ID NCT06244771

Disease control Sponsor: Frontier Medicines 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests an experimental oral drug called FMC-376 in people with advanced solid tumors (like lung, colorectal, or pancreatic cancer) that have a specific genetic change called KRAS G12C. The trial has three parts: first, finding the safest dose; then, checking how well the drug works in different cancer types. About 403 participants will take daily capsules, and researchers will monitor side effects, drug levels in the blood, and tumor response.

What this could mean

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

Active substance
FMC-376 (oral capsule)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a specific KRAS G12C mutation, potentially shrinking tumors or slowing their growth.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. It is not yet proven to be safe or effective.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 403 people

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

Started

Feb 2024

Expected to finish

Apr 2028

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: * Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors with KRAS G12C mutation * Received and progressed or been intolerant to prior standard therapy OR standard therapy is considered inappropriate OR an investigational agent is considered standard of care * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate hematological, renal, and hepatic function * Agrees not to participate in another interventional study while receiving study drug Exclusion Criteria: * Leptomeningeal disease or carcinomatous meningitis * Clinically significant toxicity resulting from prior cancer therapies * Known or suspected hypersensitivity to FMC-376 or any components of the study drug * Condition that would interfere with study drug absorption * Any illness or medical history that would impact safety or compliance with study requirements or impact ability to interpret study data

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm lung neoplasm malignant pancreatic neoplasm metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma pancreatic neoplasm

As listed by the trial registrant

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

Advanced solid tumors with KRAS G12C mutations Colorectal cancer KRAS G12C Metastatic solid tumor Non-small cell lung cancer Pancreatic cancer Solid tumor, adult Unresectable solid tumor

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

    23 sites in 3 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

  • Community Clinical Trials

    COMPLETED

    Kingwood, Texas, 77339, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Eastern Health - Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Florida Cancer Specialists and Research Institute

    COMPLETED

    Lake Mary, Florida, 32746, United States

  • GenesisCare North Adelaide

    RECRUITING

    North Adelaide, South Australia, 5006, Australia

    Contact Email: •••••@•••••

  • Icon Cancer Centre Kurralta Park

    RECRUITING

    Kurralta Park, South Australia, 5037, Australia

    Contact Email: •••••@•••••

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Korea University Anam Hospital

    RECRUITING

    Seoul, Seongbuk-gu, 02841, South Korea

  • Linear Clinical Research Ltd

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Macquarie University

    RECRUITING

    Macquarie Park, New South Wales, 2109, Australia

    Contact Email: •••••@•••••

  • Northwest Cancer Centers

    RECRUITING

    Dyer, Indiana, 46311, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Gyeonggi-do, Seongnam-si, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, Jongno-gu, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, Seodaemun-gu, 03722, South Korea

  • South Texas Accelerated Research Therapeutics, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Tasman Health Care

    RECRUITING

    Southport, Queensland, 4215, Australia

    Contact Email: •••••@•••••

  • The Catholic University of Korea, St. Vincent's Hospital

    RECRUITING

    Gyeonggi-do, Suwon-si, 16247, South Korea

  • The University of Kansas Cancer Center

    RECRUITING

    Fairway, Kansas, 66205, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UT Health San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of California Irvine (UCI) - Chao Family Comprehensive Cancer Center

    COMPLETED

    Orange, California, 92868, United States

  • University of California San Diego (UC San Diego) Health - Jacobs Medical Center - Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

More trials for these conditions

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