New combo therapy targets Hard-to-Treat RAS-Mutant cancers
NCT ID NCT07397338
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 370 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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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Get notified about this study
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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Eastern Connecticut Hematology and Oncology Associates
RECRUITINGNorwich, Connecticut, 06360, United States
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Health Partners Cancer Center at Regions Hospital
RECRUITINGSaint Paul, Minnesota, 55101, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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NEXT Dallas
RECRUITINGIrving, Texas, 75039, United States
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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NEXT Virginia
RECRUITINGFairfax, Virginia, 22031, United States
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Tennessee Oncology
RECRUITINGNashville, Tennessee, 37023, United States
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USC Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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