Testing a new antibody treatment for advanced colorectal cancer

Plain-English translation of NCT05379595 on ClinicalTrials.gov ↗ · Source last updated September 2026 · Translation generated September 2026 · How we translate trials

Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.

What is this trial?

This study is testing a new medication called to treat people with advanced colorectal cancer. is a human-made antibody designed to target specific proteins on cancer cells that help tumors grow. The trial will test whether the medication works better when given alone or when combined with standard chemotherapy drugs.

Colorectal cancer is one of the most common cancers worldwide, and many patients need new treatment options when standard therapies stop working or become less effective. This medication targets specific pathways that help cancer cells survive and resist existing treatments, offering a potentially new way to fight this disease.

Do you qualify?

You likely qualify if…

you have been diagnosed with colorectal cancer that has spread or cannot be surgically removed
your cancer cells have specific genetic patterns (wild-type KRAS, NRAS, BRAF, and no HER2 amplification)
you have an ECOG performance status of 0 or 1, meaning you are able to carry out daily activities with minimal difficulty
you have received prior chemotherapy treatments (the exact number depends on which study group you join)
you have a tumor that can be biopsied and you are willing to provide a tissue sample
you have not previously received certain types of chemotherapy or anti-EGFR treatments (depending on which study group)

You likely don't qualify if…

you have received more than 3 prior lines of chemotherapy in the metastatic setting (for monotherapy groups)
you have already received oxaliplatin-based or irinotecan-based chemotherapy in the metastatic setting (for certain combination groups)
you are unable to tolerate or have contraindications to standard chemotherapy drugs
you have significant liver, kidney, or heart function problems
your cancer cells have KRAS, NRAS, BRAF mutations, or HER2 amplification

What participation looks like

You will visit the clinic for screening over about 4 weeks, during which doctors will confirm your diagnosis and take a tissue sample. If enrolled, you will receive the medication by IV infusion on specific days throughout your treatment cycles (each cycle lasts 28 days). Depending on which group you join, you may receive the new medication alone or combined with standard chemotherapy. You will have regular check-ups, blood tests, and scans to monitor how well the treatment is working and to watch for side effects. Treatment continues until the cancer stops responding, you experience unacceptable side effects, or your doctor decides to stop—after which you'll have a follow-up visit about a month later.

AI-generated summary from trial data · Sep 5, 2026 · Not medical advice

Trial locations(53 sites)

United States

O Neal Comprehensive Cancer Center at UAB, Birmingham, Alabama

University of Southern California, Los Angeles, California

University of California, Los Angeles UCLA, Los Angeles, California

Georgetown University Hospital, Washington D.C., District of Columbia

H Lee Moffitt Cancer Center, Tampa, Florida