Metastatic Colorectal CancerAdvanced Colorectal Cancer
Investigational drug(s) / intervention(s)
RBS2418Placebo
RBS2418: 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.
Placebo: Placebo to Match RBS2418
Study summary
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression Free Survival — From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years. Time in months from randomization until the first radiographic documentation of objective progression, as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or death from any cause
Overall Survival — From randomization until death from any cause, assessed up to 2 years. Time in months from the date of randomization to the date of death from any cause
Trial sites (5)
Facility
City
Region
Status
Christiana Care
Newark
Delaware
Recruiting
Community Clinical Trials
Kingwood
Texas
Recruiting
Pan Oncology
San Juan
Puerto Rico
Recruiting
Tam Anh TP. Ho Chi Minh General Hospital
Ho Chi Minh City
Ho Chi Minh City
Recruiting
Tam Anh, Ha Noi General Hospital
Hà Nội
Vietnam
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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