Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiboscience, LLC.
About this trial
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 criteria
Qualifiers
At least 18 years of age on the day of signing informed consent.
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.
Have histologically or cytologically confirmed CRC diagnosis based on pathology report.
Willing to submit a pre-treatment tissue sample (archival, or fresh tissue if archival is not available).
Disqualifiers
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.
Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.
Trial design
Treatments tested in this trial
- RBS2418
- Placebo
Treatment groups
150 Participants
are divided into 4 treatment groupsSponsors and collaborators
Riboscience, LLC.
Lead sponsor
Tam Anh Research Institute
Collaborator
Source ClinicalTrials.gov