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New drug cocktail targets Hard-to-Treat gut cancers

NCT ID NCT05039177

Disease control Sponsor: Erasca, 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026

Summary

This study tested a new cancer drug called ERAS-007, given by mouth, together with other targeted therapies in 101 people with advanced colorectal or pancreatic cancers that have certain gene changes. The main goals were to check safety, find the best dose, and see how the drugs work in the body. The trial is now complete, and results will help guide future studies.

What this could mean

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

Active substance
ERAS-007 (a targeted cancer drug taken by mouth) combined with other drugs (encorafenib, cetuximab, or palbociclib)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced colorectal or pancreatic cancers that have specific genetic mutations.
What could go wrong
This is an early-phase trial focused on safety and dosing, not yet on effectiveness. The combination may cause side effects or fail to shrink tumors. Results may not apply to all patients.

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

101 people

The number who actually took part.

Started

Sep 2021

Finished

Jan 2026

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 to 99 years

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: * Age ≥ 18 years. * Willing and able to give written informed consent. * Have histologically or cytologically confirmed metastatic CRC harboring applicable mutation(s) (e.g., BRAF V600E; KRAS or NRAS mutations) or metastatic PDAC harboring KRAS mutation based on an analytically validated assay performed on tumor tissue in a certified testing laboratory. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Adequate bone marrow and organ function. * Have ECOG performance status of 0 or 1. * Willing to comply with all protocol-required visits, assessments, and procedures. * Able to swallow oral medication. Exclusion Criteria: * Prior therapy with a RAS, MEK, or ERK inhibitor. Depending on which treatment arm the patient is assigned, other therapies could also be prohibitive. * Anti-cancer therapy ≤ 21 days or 4 half-lives prior to first dose of study drug, whichever is shorter. * Palliative radiation ≤ 7 days prior to first dose of study drug. * Symptomatic brain metastasis or leptomeningeal disease. * Gastrointestinal conditions that may affect absorption of oral medications * Active infection requiring systemic therapy, or a known history of HIV infection, hepatitis B virus, or hepatitis C virus. * History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first study drug dose. * Active, clinically significant interstitial lung disease or pneumonitis. * Impaired cardiovascular function or clinically significant cardiovascular disease. * History of thromboembolic or cerebrovascular events ≤ 6 months prior to first dose. * Major surgery within 28 days of enrollment, or anticipation of major surgery during study treatment. * Known intolerance or contraindication to encorafenib, cetuximab, or palbociclib. * Pregnant or breastfeeding women. * Any evidence of severe or uncontrolled systemic disease or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm digestive system neoplasm Digestive System Neoplasms pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

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

Metastatic colorectal cancer Metastatic pancreatic ductal adenocarcinoma

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Henry Ford Cancer Institute

    Detroit, Michigan, 48202, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02215, United States

  • Sarah Cannon Research Institute (Tennessee Oncology)

    Nashville, Tennessee, 37203, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCSF Mount Zion Medical Ctr

    San Francisco, California, 94158, United States

  • University of Alabama at Birmingham (O'Neal Comprehensive Cancer Center)

    Birmingham, Alabama, 35233, United States

  • University of California Irvine College of Medicine

    Orange, California, 92868, United States

  • University of Washington - Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Washington University (Siteman Cancer Center)

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.