Evaluating RBS2418 for advanced colorectal cancer
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study of RBS2418 Plus Best Supportive Care (BSC) in Subjects With Advanced, Metastatic, and Progressive Colorectal Cancer
This study is testing a new immune treatment called RBS2418 to see if it can help people with advanced colorectal cancer who haven't had success with other treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Riboscience, LLC. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 3 sites (Kingwood, Texas and 2 other locations) |
| Trial ID | NCT06824064 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced, metastatic colorectal cancer who have failed or are intolerant to standard therapies.
Not a fit: Patients who have not yet received standard-of-care therapies or those with other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced colorectal cancer who have exhausted standard care options.
How similar studies have performed: While this approach is novel, similar immune modulation strategies have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kingwood, Texas and 2 other locations
- Community Clinical Trials — Kingwood, Texas, United States (Recruiting)
- Tam Anh TP. Ho Chi Minh General Hospital — Ho Chi Minh City, Ho Chi Minh City, Vietnam (Recruiting)
- Tam Anh, Ha Noi General Hospital — Hà Nội, Vietnam (Recruiting)
Study contacts
- Study coordinator: Riboscience Clinical Trials
- Email: clinicaltrials@riboscience.com
- Phone: (415) 754-3182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.