Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive 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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years, 30 days, 90 days
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Subjects will receive study treatment of RBS2418 or Placebo to Match plus Best Supportive Care with a treatment period consisting of 21-day cycles up to two years or until there is progressive disease (PD), death, withdrawal, or study completion, whichever comes first."
- "AEs will be collected until up to 30 days after the end of treatment or until resolution, whichever comes first."
- "Serious Adverse Events (SAEs) will be collected for 90 days after the end of treatment, or if the subject initiates new anti-cancer therapy, then 30 days after the end of treatment, whichever is earlier."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares RBS2418 with a placebo in adults with advanced colorectal cancer (cancer of the colon or rectum) that has spread and is getting worse. RBS2418 is designed to help the immune system fight cancer. Researchers will test its safety, side effects, and effects on the immune system and cancer.
RBS2418 is a specific immune modulator that works through the inhibition of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) and is designed to lead to anti-tumor immunity by protecting endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis and leading to the activation of antigen-presenting cells followed by T cell activation. The hypothesis is that RBS2418 versus placebo will be generally safe, well-tolerated, immunogenic, and will lead to anti-tumor responses in adult subjects for the treatment of advanced, metastatic, and progressive colorectal cancer (CRC).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are at least 18 years old when you sign the consent form.
- You have advanced colorectal cancer that has spread and is getting worse.
- You have received all approved standard treatments, could not receive or tolerate them, or chose not to receive them.
- Two scans done within 2 to 4 months of starting the study must show that your cancer is getting worse.
- A lab report from a tissue or cell sample must confirm colorectal cancer.
- You are willing to provide a stored tissue sample before treatment, or a new sample if no stored sample is available.
Who can't join
- You had approved cancer treatment within 2 weeks before your first study dose. Radiation to ease symptoms from cancer in bones or soft tissue is allowed if finished more than 7 days before that dose. Hormone replacement and birth control pills are allowed.
- Side effects from past treatment have not returned to mild levels or your usual level. Moderate nerve damage or hair loss is allowed.
- Your cancer worsened quickly during past treatment and caused your health to decline quickly.
- You had another cancer within 3 years before the study starts. Exceptions may apply for cancers with very low risk of spread or death treated with an expected cure, cancers being closely watched, or slow-growing cancers not yet treated.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (2)
DE
- Christiana Care · Newark, DE 19718More trials in Newark
TX
- Community Clinical Trials · Kingwood, TX 77339More trials in Kingwood