RECRUITING

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

Conditions

Metastatic Colorectal Cancer Advanced Colorectal Cancer Advanced, Metastatic, Progressive Colorectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-01-17

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06824064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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.

Contacts and Locations

Study Contact

Riboscience Clinical Trials

CONTACT

(415) 754-3182

clinicaltrials@riboscience.com

Tri L Phuong, MD

CONTACT

(84) 28 7102 6789

tripl@tamri.vn

Study Locations (Sites)

University of California, Los Angeles

Los Angeles, California, 90095

United States

Collaborators and Investigators

Sponsor: Riboscience, LLC.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-01-17

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Advanced, Metastatic, Progressive Colorectal Cancer

Additional Relevant MeSH Terms

Metastatic Colorectal Cancer
Advanced Colorectal Cancer