Evaluating RBS2418 for advanced colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2a clinical trial investigates the efficacy and safety of RBS2418, an immune modulator, in patients with advanced, metastatic, and progressive colorectal cancer who have not responded to standard treatments. Participants will receive either RBS2418 or a placebo alongside best supportive care, with treatment cycles lasting up to two years or until disease progression. The study aims to assess the immunogenicity of RBS2418 and its potential to activate anti-tumor responses in the immune system. Adverse events will be closely monitored throughout the trial to ensure participant safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Christiana Care
  Newark, Delaware, United States Recruiting
• Comprehensive Cancer Centers of Nevada
  Las Vegas, Nevada, United States Recruiting
• SCRI Oncology LLC
  Nashville, Tennessee, United States Recruiting
• Community Clinical Trials
  Kingwood, Texas, United States Recruiting
• Pan Oncology
  San Juan, Puerto Rico Recruiting
• Tam Anh, Ha Noi General Hospital
  Hanoi, Hanoi, Vietnam Recruiting

Study contacts

• Study coordinator: Riboscience Clinical Trials
• Email: clinicaltrials@riboscience.com
• Phone: (415) 754-3182

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.