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New pill targets KRAS cancers in early human trial

NCT ID NCT06835569

Disease control Sponsor: Alterome 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tests an oral drug called ALTA3263 in about 448 adults with advanced solid tumors (like pancreatic, lung, or colorectal cancer) that have a KRAS mutation. The main goals are to check safety, find the right dose, and see how the body processes the drug. Participants have already tried other treatments without success.

What this could mean

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

Active substance
ALTA3263 (oral tablet)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have KRAS mutations.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, not yet on effectiveness. Many drugs fail in early testing, and 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 448 people

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

Started

Mar 2025

Expected to finish

Aug 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: * Histologically confirmed diagnosis of a solid tumor malignancy harboring a KRAS mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic test. * Unresectable or metastatic disease. * Progressed on, intolerant to, or declined prior standard-of-care therapy (including targeted therapy, if applicable) appropriate to tumor type and stage * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate organ function Exclusion Criteria: * Prior treatment with a KRAS inhibitor, certain exceptions are described in the full study protocol * Known condition that prohibits the ability to swallow or absorb an oral medication. Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cancer carcinoma colonic neoplasm colorectal cancer colorectal carcinoma colorectal neoplasm lung neoplasm neoplasm Neoplasm Metastasis Neoplasms by Site non-small cell lung carcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Advanced solid tumors Cancer CRC (colorectal cancer) NSCLC (non-small cell lung cancer) Pdac - pancreatic ductal adenocarcinoma

How to take part

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

  1. The places running it

    12 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

  • Research Site

    RECRUITING

    Orlando, Florida, 32827, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    New York, New York, 10016, United States

  • Research Site

    RECRUITING

    New York, New York, 10032, United States

  • Research Site

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Research Site

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Research Site

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site #2

    RECRUITING

    San Antonio, Texas, 78229, United States

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