Recruiting

Testing a new drug combination for advanced colorectal cancer

Plain-English translation of NCT05253651 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated October 2026 · How we translate trials

Read our Colorectal Neoplasms research guide →

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing , a new medication, combined with two other cancer drugs to see if it works better than the current standard treatments for advanced colorectal cancer. The study will compare people who receive with those who receive one of the standard treatment options doctors currently use. Researchers will also track what side effects people experience with each treatment.

For people with HER2-positive colorectal cancer that has spread or cannot be removed surgically, current treatment options have limited success. This medication is being tested to see if adding to existing therapies can help more patients live longer and with better quality of life.

Do you qualify?

You likely qualify if…

you have been diagnosed with colorectal cancer that has spread to other parts of your body or cannot be removed with surgery
your cancer has a genetic marker called HER2-positive, confirmed by lab testing
you have not received any systemic cancer treatment for advanced colorectal cancer before (though you may have received up to 2 prior doses of one specific chemotherapy combination)
you are in good enough overall health to tolerate cancer treatment, with an ECOG performance status of 0 or 1
you can provide a tumor tissue sample (either archived from a previous biopsy or a new biopsy) for central laboratory testing

You likely don't qualify if…

you have received prior treatment with anti-HER2 therapy (drugs that target the HER2 marker)
you are currently experiencing severe nerve damage (Grade 3 or higher neuropathy) from previous treatments
you had radiation therapy within the past 14 days (or 7 days if stereotactic radiosurgery)
you have an active or untreated hole in your gastrointestinal tract at the time of screening
you have untreated brain tumors that are causing symptoms (though asymptomatic or previously treated brain metastases are allowed)

What participation looks like

If you enroll, you will be randomly assigned to either receive the new medication combination or one of the standard treatment options. You will visit the clinic regularly for infusions or oral medications, blood tests, and imaging scans to monitor how well the treatment is working and track any side effects. The study will follow you throughout your treatment to compare outcomes between the two groups.

AI-generated summary from trial data · Oct 12, 2026 · Not medical advice

Testing a new drug combination for advanced colorectal cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(366 sites)