Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RBS2418 Plus Best Supportive Care in Adults With Advanced, Metastatic, and Progressive Colorectal Cancer
Led by Riboscience, LLC. · Updated on 2026-05-18
150
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Riboscience, LLC.
Lead Sponsor
T
Tam Anh Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying RBS2418, an immune modulator designed to activate the body's immune cells to fight advanced, metastatic, and progressive colorectal cancer. This Phase 2a trial evaluates whether RBS2418 is safe, well-tolerated, and able to trigger anti-tumor responses compared to a placebo in adults who have not benefited from or declined standard cancer treatments. Participants will be randomly assigned to receive either RBS2418 or a matching placebo, both given orally twice daily in 21-day cycles alongside best supportive care. Treatment may continue for up to two years or until disease progression, death, withdrawal, or study completion. The study includes groups based on specific biomarkers related to ENPP1 and cGAS positivity. During the study, participants will undergo regular assessments including scans to measure disease progression and survival. Researchers will monitor side effects and serious adverse events up to 90 days after treatment ends. The main outcomes measured are progression-free survival and overall survival over two years, with additional monitoring of response duration and disease control rate.
CONDITIONS
Brief Title
Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at the time of consent
- Diagnosed with advanced, metastatic, or progressive colorectal cancer
- Have received, been ineligible for, intolerant to, or declined all approved standard treatments for metastatic colorectal cancer
- Documented disease progression based on two scans within 2 to 4 months before study start
- Histological or cytological confirmation of colorectal cancer
- Willing to provide a pre-treatment tissue sample (archival or fresh if archival unavailable)
You will not qualify if you...
- Received any approved anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy, radiation) within 2 weeks before first study dose unless recovered to Grade 1 or baseline
- Palliative radiotherapy for bone or soft tissue lesions completed less than 7 days before first study dose
- Rapid progression on prior therapy causing rapid clinical deterioration
- Other malignancies within 3 years prior to study start except low-risk or indolent tumors under surveillance or untreated
- Presence of Grade 2 or higher neuropathy or alopecia unless specified
- Use of hormone-replacement therapy or oral contraceptives allowed as exceptions to therapy restrictions
- Serious adverse events from prior treatments not resolved to Grade 1 or baseline levels before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to two years or until disease progression, death, withdrawal, or study completion
Participants receive RBS2418 or placebo plus best supportive care in 21-day cycles until disease progression, death, withdrawal, or study completion, whichever comes first.
21-day treatment cycles with visits as per protocol
Duration - Up to 90 days after treatment ends
Adverse events are monitored for up to 30 days after treatment ends; serious adverse events are monitored for up to 90 days after treatment ends or 30 days if new anti-cancer therapy is started earlier.
Visits as needed for adverse event monitoring
Trial Site Locations
Total: 5 locations
1
Christiana Care
Newark, Delaware, United States, 19718
Actively Recruiting
2
Community Clinical Trials
Kingwood, Texas, United States, 77339
Actively Recruiting
3
Pan Oncology
San Juan, Puerto Rico, 00935
Actively Recruiting
4
Tam Anh TP. Ho Chi Minh General Hospital
Ho Chi Minh City, Ho Chi Minh City, Vietnam, 70000
Actively Recruiting
5
Tam Anh, Ha Noi General Hospital
Hà Nội, Vietnam, 10000
Actively Recruiting
Research Team
R
Riboscience Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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