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Targeted drug combo takes aim at hard-to-treat KRAS-mutant colorectal cancer

NCT ID NCT07814417

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether adding olomorasib, an experimental drug that targets the KRAS G12C mutation, to cetuximab and standard chemotherapy (mFOLFOX6) helps people with advanced colorectal cancer that cannot be removed by surgery or has spread. The trial enrolls about 50 adults whose tumors carry the KRAS G12C mutation and who have not yet received treatment for advanced disease. The main goals are to measure how many participants respond to the combination and how long they live without their cancer getting worse, while tracking side effects and how the body processes olomorasib.

What this could mean

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

Active substance
olomorasib, an experimental KRAS G12C inhibitor, given with cetuximab and standard chemotherapy
What this could lead to
If the combination works, it could offer a new targeted option for people with KRAS G12C-mutant colorectal cancer that has spread or cannot be removed by surgery.
What could go wrong
This is a small phase 2 trial with 50 participants, so results may not hold in larger studies. Combining three drug types may cause side effects that limit how well people tolerate treatment.

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 50 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 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: * Histologically or cytologically confirmed colorectal cancer (CRC) with Stage III or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy. * Must have disease with evidence of KRAS G12C mutation * Have measurable disease per RECIST v1.1. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Ability to swallow capsules. * Have adequate laboratory parameters. * Have not received treatment for their CRC that has spread to other parts of the body. * 1-2 cycles of FOLFOX prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated. Exclusion Criteria: * Have active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease. * Have a clinically significant active malabsorption syndrome or other conditions likely to affect gastrointestinal absorption of the orally administered study treatments. * Have known untreated active central nervous system metastases or carcinomatous meningitis. * Have known additional malignancy that is progressing or has required treatment within the past 2 years. * Have uncontrolled, significant cardiovascular disease or cerebrovascular disease. * Have an active fungal, bacterial, or active, untreated viral infection. * Have human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma or Multicentric Castleman's Disease. * Have known B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E gene mutation. * Have confirmed Microsatellite Instability-High/deficient Mismatch Repair (MSI-H/dMMR). * Individuals with known low or absent dihydropyrimidine dehydrogenase activity. * Have known positive Immunoglobulin E (IgE) antibodies against galactose-α-1,3-galactose (alpha-gal). * Have received adjuvant, neoadjuvant, concurrent chemoradiotherapy, or consolidation therapy if treatment was completed less than 6 months prior to enrollment. * Are pregnant, breastfeeding, or intend to become pregnant during the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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