Actively Recruiting
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
Led by Riboscience, LLC. · Updated on 2025-12-19
164
Participants Needed
14
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with other cancer treatments including monotherapy and in combination with other cancer treatments including immunotherapy or chemotherapy. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or other approved anticancer therapies or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors. The phase 1a (dose escalation phase) has been completed. The Phase 1b expansion phase of the study has been increased in size and scope.
CONDITIONS
Official Title
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be willing and able to provide written informed consent for the study
- Be 18 years of age or older at the time of consent
- Have advanced unresectable, recurrent, or metastatic tumors with no further standard of care therapies available
- Have histologically or cytologically confirmed cancer diagnosis
- Have predicted life expectancy of at least 3 months
- Have measurable disease based on RECIST 1.1 criteria
- Have an ECOG performance status of 0, 1, or 2 within 14 days before first treatment
- Willing to provide pre-treatment and on-treatment tumor tissue samples unless biopsy is clinically contraindicated
- Female subjects of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Demonstrate adequate organ function based on hematological, renal, hepatic, and coagulation tests within 14 days before first treatment
- Women of childbearing potential must agree to abstinence or use two effective contraceptive methods during treatment and for at least 120 days after last dose
- Male subjects must agree not to father a child during treatment and for at least 120 days after last dose, either by abstinence, surgical sterilization, or effective contraception
You will not qualify if you...
- Use of systemic anti-cancer therapy within 2 weeks before first dose unless combined with RBS2418 per protocol and approved
- Unrecovered adverse events from prior therapies above Grade 1 except allowed exceptions
- Evidence of rapid progression on prior therapy causing rapid clinical deterioration
- Participation in other investigational trials or use of investigational devices within 28 days before Day 1
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial effusions, or ascites needing recurrent drainage
- Other malignancies within 3 years except low-risk or indolent tumors
- History of severe allergic or hypersensitivity reactions to similar biologics
- Known hypersensitivity to study drugs or components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or evidence of interstitial lung disease
- Treatment with systemic immunosuppressants within 2 weeks before study
- Active HIV requiring therapy or uncontrolled HIV
- Active hepatitis B or C requiring treatment
- Severe infections requiring hospitalization or systemic therapy within 4 weeks before enrollment
- Use of therapeutic antibiotics within 2 weeks before Day 1
- Any condition or therapy that could interfere with study participation or results
- Prolonged QT/QTc interval or risk factors for Torsades de Pointes
- Gastrointestinal disorders affecting drug absorption
- Prior allogeneic stem cell or solid organ transplant
- Receipt of live attenuated vaccine within 28 days before enrollment
- Active psychiatric or substance abuse disorders interfering with trial cooperation
- Prisoner or involuntarily incarcerated individuals
- Pregnant, lactating, or intending pregnancy or fatherhood during study and 120 days after last dose of study drugs
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
University of Arizona
Tucson, Arizona, United States, 85724
Actively Recruiting
3
Stanford Cancer Institute
Palo Alto, California, United States, 94305
Actively Recruiting
4
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, United States, 90404
Actively Recruiting
5
Christiana Care Health Services
Newark, Delaware, United States, 19713
Actively Recruiting
6
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
8
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
9
American Oncology Partners of Maryland
Bethesda, Maryland, United States, 20817
Actively Recruiting
10
Ichan School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
11
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078
Completed
12
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37235
Actively Recruiting
13
Tranquil Research
Webster, Texas, United States, 77598
Withdrawn
14
NEXT Virigina
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
R
Riboscience Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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