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New combo therapy targets Hard-to-Treat RAS-Mutant cancers

NCT ID NCT07397338

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 6 times

Summary

This study tests whether combining experimental RAS(ON) inhibitors with ivonescimab (an immunotherapy) can shrink or control advanced solid tumors that have a RAS mutation. About 370 adults with cancers like non-small cell lung cancer or colorectal cancer will receive these drugs orally or by IV. The goal is to check safety and early signs of tumor shrinkage.

What this could mean

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

Active substance
RAS(ON) inhibitors (daraxonrasib, elironrasib, zoldonrasib) plus ivonescimab, with or without chemotherapy or cetuximab
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have a RAS mutation and have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the combination may not prove effective or safe. Side effects from the drugs are possible and not yet fully known.

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 370 people

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

Started

Jan 2026

Expected to finish

May 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: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS. * Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration). * Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \& B for Part 2 Dose Expansion). * Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion). * Measurable disease per RECIST v1.1 * Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine). * Able to take oral medications. Exclusion Criteria: * Head and neck squamous cell carcinoma. * Any conditions that may affect the ability to take or absorb study drug. * Major surgery within 4 weeks prior to receiving study drug(s). * Patient is unable or unwilling to comply with protocol-required study visits or procedures. * Other inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    9 sites. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Eastern Connecticut Hematology and Oncology Associates

    RECRUITING

    Norwich, Connecticut, 06360, United States

  • Health Partners Cancer Center at Regions Hospital

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • NEXT Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Tennessee Oncology

    RECRUITING

    Nashville, Tennessee, 37023, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

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