Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: 1. At least 18 years of age on the day of signing informed consent. 2. Male and female participants with advanced, unresectable HCC who are eligible to receive STRIDE regimen as first line therapy. 3. Willing to submit a pre-treatment tissue sample (archival or fresh tissue if archival is not available). Exclusion Criteria: 1. BCLC stage D disease at the time of screening or prior to first dose of RBS2418. 2. 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. 3. Eligible for curative treatments (e.g., surgical resection, liver transplantation, or local ablation). 4. Evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.