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New drug targets tough cancer mutation in early trial

NCT ID NCT06227377

Disease control Sponsor: Quanta Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-stage trial tests a new drug called QTX3034, alone or with another drug (cetuximab), in people with advanced solid tumors that have a specific genetic change called KRAS G12D. The main goals are to check safety and find the right dose. About 250 participants will take part. Success could lead to better treatments for these hard-to-treat cancers.

What this could mean

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

Active substance
QTX3034 (a drug) and cetuximab (a combination drug)
What this could lead to
If this works, it could point toward a new treatment option for people with hard-to-treat cancers that have a specific KRAS mutation.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. It is small and may not lead to a proven treatment. Side effects are unknown.

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 250 people

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

Started

Feb 2024

Expected to finish

Apr 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: * Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic * Part 1: - Advanced solid tumors with at least 1 prior systemic therapy * Evaluable or Measurable disease per RECIST 1.1. * Parts 2 and 3: Measurable disease per RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate organ function Exclusion Criteria: * Prior treatment with a KRAS inhibitor * Active brain metastases or carcinomatous meningitis * History of other malignancy within 2 years * Significant cardiovascular disease * Disease or disorder that may pose a risk to patient's safety Other protocol-defined Inclusion/Exclusion Criteria may apply

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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 places running it

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

  2. 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 ↗

  3. 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

Locations

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • MD Anderson

    RECRUITING

    Houston, Texas, 77030, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • NEXT Oncology Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • SCRI- Nashville

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START San Antonio, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute (SCRI)

    RECRUITING

    Denver, Colorado, 80218, United States

  • Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • UCLA Hematology/Oncology

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Utah, Huntsman Cancer Center

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06511, United States

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