What this study is
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.
What's being tested
- RBS2418
Intervention · DRUG
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.
- STRIDE (durvalumab + tremelimumab)
Intervention · DRUG
STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
Study details
- Official title
- 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.
- Conditions
- Advanced Unresectable Hepatocellular Carcinoma
- Enrolling
- 220 people
- Starts
- 2026-04-10
- Est. completion
- 2027-08
- Design
- Open-label, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- At least 18 years of age on the day of signing informed consent.
- Male and female participants with advanced, unresectable HCC who are eligible to receive STRIDE regimen as first line therapy.
- Willing to submit a pre-treatment tissue sample (archival or fresh tissue if archival is not available).
You can't join if
- BCLC stage D disease at the time of screening or prior to first dose of RBS2418.
- Child-Pugh class equal or higher than B8 at the time of screening or within 7 days prior to the first dose of study treatment.
- Eligible for curative treatments (e.g., surgical resection, liver transplantation, or local ablation).
- Evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openJohns Hopkins
Baltimore, Maryland, United States
RecruitingVanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
RecruitingUniversity of Texas Southwestern
Dallas, Texas, United States
RecruitingSTART Dallas Fort Worth
Fort Worth, Texas, United States
Recruiting
Study team
Sponsor
Riboscience, LLC.
Study ID RBS2418-2002
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.