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New pill targets stubborn colorectal cancer mutation

NCT ID NCT07659795

Disease control Sponsor: Verastem, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 19 times

Summary

This study tests an experimental pill called VS-7375, designed to block a specific cancer-driving protein (KRAS G12D). The trial includes people with metastatic colorectal cancer that has this mutation. Some participants receive VS-7375 alone, others get it combined with an antibody therapy or with antibody therapy plus chemotherapy. The goal is to see if these combinations can shrink tumors and control the disease.

What this could mean

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

Active substance
VS-7375
What this could lead to
If successful, this could provide a new targeted treatment option for people with a hard-to-treat form of colorectal cancer that has spread.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not work as hoped or could cause significant side effects. Results may not apply to all patients.
Why investors are watching

Verastem is a very small company, so this phase 2 trial of its oral drug VS-7375 in metastatic colorectal cancer is a major test. The trial checks whether the drug works alone, with an EGFR antibody, or with the antibody plus chemotherapy. A clear result matters because this drug targets a specific KRAS mutation, and the company's future depends on showing it helps patients.

If it works: A positive result could show that VS-7375 controls the disease in a hard-to-treat cancer, which might lead to further development and partnerships. For a micro-cap company, a successful readout could be a turning point that validates its main drug candidate.

If it fails: Trials often fail, and this one could show the drug is unsafe or does not shrink tumors. A failure or delay would be a serious setback for Verastem, possibly limiting its ability to raise money or continue the program.

AI-written from the trial record. Speculative, and not investment advice.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Jul 2026

Expected to finish

Dec 2028

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: * Histopathology confirmed metastatic CRC * Measurable disease per RECIST 1.1 * Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing) * ECOG PS=0 or 1 2L+ patients: * Must have received at least 1 standard chemotherapy for metastatic colorectal adenocarcinoma * Have documented disease progression during or following their most recent prior line of therapy * Have either stable disease, partial response (PR), or complete response (CR) by RECIST v1.1 as the best overall response (BOR) during at least 1 prior systemic therapy. 1L patients: * Treatment-naïve or received no more than 1 cycle of standard systemic therapy for metastatic disease. Exclusion Criteria: * Have any other documented co-existing common RAS mutation(s) * Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter * Major surgery within 4 weeks of first treatment dose * Radiation therapy (RT) within 1 week of first treatment dose * Receipt of prior direct RAS inhibitor * Receipt of more than 1 investigational therapy * Untreated or symptomatic CNS metastasis * Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter * Receipt of PPI or H2 blocker within 5 days * Inability to swallow oral medication * Other protocol-defined inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Colorectal cancer

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

    16 sites in 2 countries. 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

Locations

  • Icon Cancer Centre Adelaide

    RECRUITING

    Kurralta Park, South Australia, 5037, Australia

  • Icon Cancer Centre South Brisbane

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Indiana University, Simon Comprehensive Cancer Center

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Macquarie University Hospital

    RECRUITING

    Macquarie Park, New South Wales, 2109, Australia

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • START Dallas Fort Worth

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • START Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Sarah Cannon Research Institute Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

    Contact Email: •••••@•••••

  • UVA Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Valkyrie Clinical Trials (contact for more locations)

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Mason Medical Center

    RECRUITING

    Seattle, Washington, 98101, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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