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New drug RBS2418 aims to rev up immune system against tough colorectal cancer

NCT ID NCT06824064

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

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

Started

Jan 2025

Expected to finish

Dec 2027

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: 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.

  1. The places running it

    5 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Christiana Care

    RECRUITING

    Newark, Delaware, 19718, United States

  • Community Clinical Trials

    RECRUITING

    Kingwood, Texas, 77339, United States

  • Pan Oncology

    RECRUITING

    San Juan, 00935, Puerto Rico

  • Tam Anh TP. Ho Chi Minh General Hospital

    RECRUITING

    Ho Chi Minh City, Ho Chi Minh City, 70000, Vietnam

  • Tam Anh, Ha Noi General Hospital

    RECRUITING

    Hà Nội, 10000, Vietnam

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