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New pill targets tough pancreatic cancer mutation

NCT ID NCT07644559

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 04, 2026 · Updated 25 times

Summary

This study tests a new oral drug, VS-7375, alone or with another drug (cetuximab), in 180 people with metastatic pancreatic cancer that has a specific genetic change called KRAS G12D. The goal is to see if the drug shrinks tumors and is safe. Participants must have this mutation and be in relatively good health.

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 (a pill that targets a specific cancer mutation) and cetuximab (an infusion drug)
What this could lead to
If successful, this could provide a new treatment option for people with a hard-to-treat form of pancreatic cancer that has a specific genetic mutation.
What could go wrong
This is a phase 2 trial, so it's still early. The drug may not work better than current treatments, and side effects could be significant. Results may not apply to all patients.
Why investors are watching

Verastem is a very small company, so this phase 2 trial of VS-7375 in pancreatic cancer is a major test of its pipeline. The drug targets a specific KRAS mutation found in many pancreatic tumors, and the trial measures whether it controls the disease alone or with cetuximab. A clear result will shape the company's future value because this is one of its few late-stage assets.

If it works: If VS-7375 shows meaningful disease control in patients with this hard-to-treat cancer, Verastem could advance the drug to a larger trial or attract a partnership. That would validate its research and give the company a path forward.

If it fails: Pancreatic cancer trials often fail, and a negative or unclear result could set the program back or end it. For a micro-cap company with few other options, that would be a serious blow to its prospects.

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 180 people

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

Started

Jun 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 PDAC * Measurable disease per RECIST 1.1 * Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing) * ECOG PS=0 or 1 Adequate organ function VS-7375 + cetuximab (2L PDAC) : -Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months VS-7375 + cetuximab (1L PDAC) : -Treatment-naïve or received ≤ 1 cycle of SoC 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; RT to brain or lung within 2 weeks of first treatment dose * History of drug-induced Interstitial Lung Disease * Receipt of prior direct RAS inhibitor * 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.

pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

G12D mutated KRAS Pancreatic ductal adenocarcinoma (PDAC)

How to take part

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

  1. The places running it

    29 sites in 3 countries. 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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • ICON Cancer Centre

    RECRUITING

    South Brisbane, QLD 4101, Australia

  • ICON Kurralta Park

    RECRUITING

    Kurralta Park, South Australia, 5037, Australia

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77054, United States

  • Macquarie University Hospital

    RECRUITING

    Sydney, New South Wales, 2019, Australia

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinical Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinical Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NYU-Manhattan

    RECRUITING

    New York, New York, 10016, United States

  • Princess Margaret Cancer Center

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • START Dallas

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • START- Los Angeles

    RECRUITING

    Los Angeles, California, 90025, United States

  • START- Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START- San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • UVA Health

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • UW Health

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Mason

    RECRUITING

    Seattle, Washington, 98101, United States

  • Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

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