RecruitingPhase 2NCT07175441

Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma

A Phase 2a, Multicenter, Randomized, Open-Label Study to Assess the Efficacy, Safety, and Tolerability of RBS2418 in Combination With Tremelimumab Plus Durvalumab for Participants With Advanced Unresectable Hepatocellular Carcinoma

Sponsor

Riboscience, LLC.

Enrollment

220 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Advanced Unresectable Hepatocellular Carcinoma

Summary

RBS2418 is a targeted immune modulator that inhibits ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1). It is designed to promote anti-tumor immunity by preserving endogenous 2'-3' cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) from hydrolysis, thereby activating antigen-presenting cells and promoting robust T cell activation. Ideally, RBS2418 acts synergistically with CTLA-4 inhibitors, such as those in the STRIDE regimen (Tremelimumab plus Durvalumab). The hypothesis is that RBS2418 combined with STRIDE will be safe, well-tolerated, highly immunogenic, and enhance anti-tumor responses in adult participants with advanced, unresectable hepatocellular carcinoma (HCC) compared to STRIDE alone.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called RBS2418 to a standard immunotherapy combination (tremelimumab + durvalumab, known as STRIDE) improves outcomes for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be removed by surgery. **You may be eligible if...** - You are 18 years or older - You have advanced, unresectable hepatocellular carcinoma (liver cancer) - You are eligible to receive the STRIDE immunotherapy regimen as your first treatment - You are willing to provide a tissue sample for testing **You may NOT be eligible if...** - Your liver cancer is at an advanced BCLC Stage D (the most severe stage) - Your liver function is significantly impaired (Child-Pugh score B8 or higher) - Your cancer could potentially be treated with surgery or local ablation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRBS2418

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.

DRUGSTRIDE (durvalumab + tremelimumab)

STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks

Locations(4)

Johns Hopkins

Baltimore, Maryland, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

START Dallas Fort Worth

Fort Worth, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07175441

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