New drug RBS2418 aims to rev up immune system against tough colorectal cancer
NCT ID NCT06824064
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2a trial tests an experimental drug called RBS2418 in 150 adults with advanced, metastatic colorectal cancer that has worsened despite standard treatments. The drug is designed to help the immune system recognize and attack cancer cells. Participants will receive either RBS2418 or a placebo, alongside best supportive care, to see if the drug can slow tumor growth and improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RBS2418
- What this could lead to
- If it works, this could offer a new treatment option for people with advanced colorectal cancer who have run out of standard therapies.
- What could go wrong
- This is an early Phase 2a trial with only 150 participants, so results may not confirm benefit. The drug may not slow tumor growth or could cause side effects.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2027
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: 1. At least 18 years of age on the day of signing informed consent. 2. Male and female subjects with advanced, metastatic, progressive CRC who have received, been ineligible for, intolerant to, or declined all approved standard of care (SOC) therapies for metastatic CRC, as per local SOC treatment regimens. Additionally, subjects must have documented PD based on two scans performed within 2 to 4 months of study initiation. 3. Have histologically or cytologically confirmed CRC diagnosis based on pathology report. 4. Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available). Exclusion Criteria: 1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy, systemic immunotherapy, or radiation therapy within 2 weeks prior to the first dose of study treatment; or if subject has not recovered (i.e., ≤ to Grade 1 or returned to baseline level) from AEs due to a previously administered agent; the following exceptions are allowed: * Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \>7 days prior to the first dose of study treatment. * Hormone-replacement therapy or oral contraceptives. * Subjects with Grade 2 neuropathy or Grade 2 alopecia. 2. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration. 3. Malignancies other than indications open for enrollment within 3 years prior to Day 1, except for those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active surveillance, or treatment-naïve for indolent tumors.
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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.
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The places running it
5 sites in 3 countries. 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
Locations
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Christiana Care
RECRUITINGNewark, Delaware, 19718, United States
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Community Clinical Trials
RECRUITINGKingwood, Texas, 77339, United States
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Pan Oncology
RECRUITINGSan Juan, 00935, Puerto Rico
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Tam Anh TP. Ho Chi Minh General Hospital
RECRUITINGHo Chi Minh City, Ho Chi Minh City, 70000, Vietnam
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Tam Anh, Ha Noi General Hospital
RECRUITINGHà Nội, 10000, Vietnam
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a hyaluronic acid drug combo outperform bevacizumab in Hard-to-Treat colon cancer?
- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?