Evaluation of RBS2418 in Patients with Advanced, Metastatic, and Progressive Colorectal Cancer

Launched by RIBOSCIENCE, LLC. · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RBS2418 for adults with advanced, metastatic colorectal cancer (CRC) that has continued to progress despite other therapies. RBS2418 is designed to help the immune system recognize and attack cancer cells more effectively. The researchers want to see if RBS2418 is safe, well-tolerated, and can help slow down or stop the growth of the cancer compared to a placebo (a treatment that does not contain the active drug).

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with advanced colorectal cancer that has not responded to standard treatments. They should also have documented evidence of cancer progression based on recent scans. Participants will need to provide a tissue sample for testing. Those who have received certain cancer treatments or have rapidly worsening cancer may not be eligible. If you join the trial, you will receive careful monitoring and support throughout the study, and you will contribute to important research that could help improve future treatments for colorectal cancer.

Gender

ALL

Eligibility 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.