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

NCT ID NCT07207707

Disease control Sponsor: Kumquat Biosciences Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called KQB548 in people with advanced solid tumors (like pancreatic, colorectal, or lung cancer) that have a specific KRAS G12D mutation. The main goals are to find a safe dose and see if the drug can shrink tumors. About 78 participants who have already tried other treatments 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 78 people

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

Started

Sep 2025

Expected to finish

Mar 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 confirmed, locally advanced or metastatic PDAC, CRC, or NSCLC with a KRAS G12D mutation * Progressed on, or intolerant to at least one prior line of systemic standard of care therapy * Measurable disease according to RECIST v1.1 * Adequate organ function Exclusion Criteria: * Previous treatment with a KRAS G12D inhibitor or pan-RAS inhibitor * History of intestinal disease, uncontrolled inflammatory bowel disease (e.g., Crohn's disease, Ulcerative Colitis), major esophageal or gastric surgery, or other gastrointestinal conditions (e.g., uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study intervention or result in inability to swallow oral medications * Poorly controlled ascites and/or pleural effusion * Requires treatment with a strong and/or moderate CYP3A inhibitor or inducer * Requires treatment with a proton-pump inhibitor

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Conditions

The condition(s) this trial relates to.

cancer colorectal cancer non-small cell lung carcinoma pancreatic ductal adenocarcinoma

As listed by the trial registrant

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

Solid tumor malignancies

How to take part

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

  1. The places running it

    13 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

  • Fred Hutchison Cancer Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Oncology - Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Oncology - Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Oncology - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • SCRI - Denver

    RECRUITING

    Denver, Colorado, 80218, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • The Christ Hospital

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of California, San Diego

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Utah - Huntsman Cancer Institute

    RECRUITING

    Salt Lake City, Utah, 84112, United States

More trials for these conditions

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