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New pill targets Hard-to-Treat KRAS cancers in first human trial

NCT ID NCT07458347

Disease control Sponsor: Kestrel Therapeutics, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This early-phase trial is testing an experimental oral drug called KST-6051 in adults with advanced or metastatic solid tumors that have a KRAS mutation, including certain lung, pancreatic, and colorectal cancers. The main goal is to check the drug's safety and how the body processes it. About 145 participants will take the pill by mouth, and researchers will also look for any signs that the drug is shrinking tumors.

What this could mean

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

Active substance
KST-6051 (an oral tablet)
What this could lead to
If this drug is safe and shows signs of shrinking tumors, it could point toward a new treatment option for people with KRAS-mutant cancers like lung, pancreatic, or colorectal cancer.
What could go wrong
This is a very early (Phase 1) trial focused on safety, not effectiveness. The drug may not work or could cause serious side effects. Only a small number of people will receive it at first.

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 145 people

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

Started

Apr 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Age ≥ 18 years. 2. Willing and able to give written informed consent. 3. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor. 4. Documentation of KRAS mutation prior to the first dose of trial drug(s). 5. Progressed on or intolerant to standard treatment(s). 6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 7. Adequate cardiovascular, hematological, liver, and renal function. 8. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1). Exclusion Criteria: 1. Previous or current treatment with RAS or KRAS inhibitors. 2. Central nervous system (CNS) tumors or metastases. 3. Inability to swallow oral medications. 4. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial. Other inclusion/exclusion criteria are specified in the protocol.

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Conditions

The condition(s) this trial relates to.

Biliary Tract Neoplasms cholangiocarcinoma colonic neoplasm colorectal cancer colorectal neoplasm endometrium neoplasm lung neoplasm Neoplasm Metastasis non-small cell lung carcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm rectal neoplasm

As listed by the trial registrant

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

KRAS-mutant colorectal cancer (CRC) KRAS-mutant non-small cell lung cancer (NSCLC) KRAS-mutant pancreatic ductal adenocarcinoma (PDAC) Other KRAS-mutant 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

    9 sites. 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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Florida Cancer Specialists

    RECRUITING

    Sarasota, Florida, 34232, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Mass General Brigham Cancer Institute at Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States