drugset / Trial / NCT07175441

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

NCT07175441

Phase 2 Recruiting 220 enrolled Riboscience, LLC.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-04-10
Primary completion
2027-04
Completion
2027-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator RBS2418 Small molecule 200 mg Oral
Comparator RBS2418 Small molecule 800 mg Oral
Comparator Durvalumab Monoclonal antibody 1500 mg Intravenous
Comparator Tremelimumab Monoclonal antibody 300 mg Intravenous