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New drug targets tough cancers with KRAS G12V mutation

NCT ID NCT06715124

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new drug called QTX3544, alone or with another drug (cetuximab), in people with advanced solid tumors that have a specific genetic change (KRAS G12V). The main goals are to check safety and find the right dose. About 237 adults with tumors that have not responded to prior treatment will take part.

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 237 people

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

Started

Jan 2025

Expected to finish

Jan 2029

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 G12V mutations 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 one prior systemic therapy. * Evaluable and measurable disease per RECIST v1.1. * Part 2 and 3: Measurable disease per RECIST v1.1. Exclusion Criteria: * Active brain metastasis or carcinomatous meningitis * Significant cardiovascular disease * Active infection requiring intravenous (IV) antibiotics * Prior treatment with a KRAS inhibitor 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.

Advanced solid tumors

Contacts and locations

Locations

  • Duke Cancer Center

    Durham, North Carolina, 27705, United States

  • Florida Cancer Specialists & Research Institute

    Sarasota, Florida, 34232, United States

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112, United States

  • Sarah Cannon Research Institute

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • South Texas Accelerated Research Therapeutics Mountain Region, LLC

    West Valley City, Utah, 84119, United States

  • South Texas Accelerated Research Therapeutics, LLC Midwest

    Grand Rapids, Michigan, 49546, United States

  • South Texas Accelerated Research Therapeutics, LLC San Antonio

    San Antonio, Texas, 78229, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06511, United States

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