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New cocktail of targeted drugs and chemo takes on pancreatic cancer

NCT ID NCT05669482

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests whether adding two targeted drugs (avutometinib and defactinib) to standard chemotherapy can help people with metastatic pancreatic cancer that hasn't been treated yet. About 40 adults with this cancer will receive the combination. The goal is to find the safest dose and see if it shrinks tumors or slows 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
avutometinib and defactinib (targeted drugs) plus gemcitabine and nab-paclitaxel (chemotherapy)
What this could lead to
If successful, this could lead to a more effective first-line treatment for metastatic pancreatic cancer, potentially shrinking tumors and delaying disease progression.
What could go wrong
This is an early-phase trial with only 40 participants, so results may not apply to all patients. The drug combination may cause significant side effects or fail to improve outcomes over standard chemo alone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 40 people

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

Started

Mar 2023

Expected to finish

Aug 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: * Male or female subjects ≥ 18 years of age * Histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma. * An Eastern Cooperative Group (ECOG) performance status ≤ 1 * Measurable disease according to RECIST 1.1 * Adequate organ function * Adequate cardiac function * Agreement to use highly effective method of contraceptive Exclusion Criteria: * Patients with pancreatic neuroendocrine tumors * Prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma * Prior treatment with inhibitors of the RAS /MAPK pathway \[e.g. MEK inhibitors\] or inhibitors of FAK * History of prior malignancy, with the exception of curatively treated malignancies * Major surgery within 4 weeks (excluding placement of vascular access) * Concurrent heart disease or severe obstructive pulmonary disease * Concurrent ocular disorders * Active skin disorder that has required systemic therapy within the past 1 year * Patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome * Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm metastatic malignant neoplasm Neoplasm Metastasis pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

KRAS activating mutation Malignant neoplasm of pancreas Metastatic cancer Neoplasms, pancreatic Pancreas cancer

Contacts and locations

Locations

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • New York Presbyterian/Weill-Cornell Medical Center

    New York, New York, 10021, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Virginia Mason Medical Center

    Seattle, Washington, 98101, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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