RBS2418 + Tremelimumab + Durvalumab for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of treatments to determine if they work better together against liver cancer. It focuses on a new drug, RBS2418, designed to boost the body's immune response to cancer, alongside Tremelimumab and Durvalumab, both immunotherapy drugs. The goal is to see if this combination can improve outcomes for individuals with advanced liver cancer that cannot be surgically removed. Suitable candidates for this trial have inoperable liver cancer and can begin treatment with the STRIDE regimen. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that RBS2418 was well-tolerated in early studies. Tests with 19 patients revealed that different doses did not cause any serious side effects. The treatment was deemed safe, as no severe problems occurred at any dose tested.
Tremelimumab and Durvalumab are established treatments in cancer therapy. They have been used together in the STRIDE regimen for liver cancer. Since these drugs are approved for other conditions, their safety is well-documented, although individual reactions can vary.
Overall, combining RBS2418 with Tremelimumab and Durvalumab aims to be both safe and effective. However, as with any treatment, it is important to consider all potential risks and benefits and discuss them with healthcare providers.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for liver cancer because they combine innovative therapies that may enhance immune system responses. Durvalumab and Tremelimumab are both immune checkpoint inhibitors, which work by blocking proteins that prevent the immune system from attacking cancer cells. RBS2418 is unique because it's an investigational agent designed to potentially boost the effectiveness of these immune therapies through a novel mechanism. This combination could offer a more robust attack on liver cancer cells compared to current standard treatments like sorafenib or lenvatinib, which primarily target cancer growth pathways. By harnessing and strengthening the body’s own immune response, these treatments hold the promise of improved outcomes for patients.
What evidence suggests that this trial's treatments could be effective for liver cancer?
Research has shown that RBS2418 might help fight liver cancer by boosting the immune system. It stops an enzyme called ENPP1 from breaking down a molecule known as cGAMP, which activates immune cells to attack cancer. In animal studies, RBS2418 significantly slowed tumor growth and extended survival. In this trial, some participants will receive RBS2418 combined with the STRIDE treatment, which includes Tremelimumab and Durvalumab. This combination is expected to enhance the body's ability to fight tumors and might be more effective than the STRIDE treatment alone, which is being tested in a separate arm of the trial.16789
Are You a Good Fit for This Trial?
Adults with advanced, unresectable hepatocellular carcinoma (a type of liver cancer) can join this trial. Participants should not have had prior treatments for their cancer and must be able to handle the side effects of immunotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive RBS2418 at two different dose levels in combination with STRIDE or STRIDE alone in 28-day cycles up to two years or until progression, death, withdrawal, or study completion
Follow-up
Participants are monitored for adverse events and overall survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
- RBS2418
- Tremelimumab
Trial Overview
The study is testing RBS2418 combined with a known immunotherapy regimen called STRIDE (Tremelimumab plus Durvalumab). It's designed to see if adding RBS2418 improves the body's immune response against liver cancer compared to using STRIDE alone.
How Is the Trial Designed?
3
Treatment groups
Active Control
STRIDE regimen
RBS2418 800 mg PO, BID in combination with STRIDE regimen
RBS2418 200 mg PO, BID in combination with STRIDE regimen
Find a Clinic Near You
Who Is Running the Clinical Trial?
Riboscience, LLC.
Lead Sponsor
Citations
Study Details | NCT07175441 | Evaluation of RBS2418 in ...
The hypothesis is that RBS2418 combined with STRIDE will be safe, well-tolerated, highly immunogenic, and enhance anti-tumor responses in adult ...
RBS2418, Tremelimumab, and Durvalumab for Advanced ...
This study focuses on testing a combination of medications for people with advanced liver cancer, specifically those whose cancer cannot be surgically removed. ...
3.
mountsinai.org
mountsinai.org/clinical-trials/rbs2418-evaluation-in-subjects-with-unresectable-metastatic-tumorsEvaluation of RBS2418 in Subjects With Advanced ...
Have histologically or cytologically confirmed cancer diagnosis based on pathology report. 5. Have a predicted life expectancy of greater or equal to 3 months.
Evaluation of RBS2418 in Subjects With Advanced, ...
RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with other cancer treatments ...
5.
aacrjournals.org
aacrjournals.org/cancerres/article/84/6_Supplement/2472/741183/Abstract-2472-Inhibition-of-ENPP1-catalyzed-ATPAbstract 2472: Inhibition of ENPP1 catalyzed ATP and cGAMP ...
In the Hepa1-6 model treatment with RBS2418 for either 2 or 10 days resulted in significant reduction of tumor growth and prolongation of ...
Project Details - NIH RePORTER
Riboscience has successfully advanced an ENPP1 inhibitor, RBS2418, to Phase 1a/1b and the clinical results have demonstrated that RBS2418 can fully inhibit ...
7.
withpower.com
withpower.com/trial/phase-2-advanced-unresectable-hepatocellular-carcinoma-9-2025-5e51aRBS2418 + Tremelimumab + Durvalumab for Liver Cancer
The hypothesis is that RBS2418 combined with STRIDE will be safe, well-tolerated, highly immunogenic, and enhance anti-tumor responses in adult participants ...
169P Immunomodulatory effects of RBS2418, an oral ...
Liver mets were shown to negatively predict the success of immuno- therapy (as opposed to chemotherapy [chemo] or targeted therapy) in several cancer types.
Methods
Results: The first 3 dose levels evaluated to date in 19 patients were safe and well tolerated with no DLTs. Median plasma concentrations of RBS2418 increased ...
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