drugset / Trial / NCT07175441
Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |