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.
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).
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.
Parallel
RBS2418
DrugRBS2418 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)
DrugSTRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
Progression Free Survival (PFS)
Time in months from randomization until the first radiographic documentation of objective progression, as assessed using RECIST 1.1, or death from any cause.
Overall Survival (OS)
Time in months from the date of randomization to the date of death from any cause.
Overall Response Rate (ORR) by RECIST 1.1
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) during the study using RECIST 1.1, among those with measurable disease.
Duration of Response (DOR) by RECIST 1.1
DOR is defined as time from initial response to disease progression or death.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who achieve a complete response (CR), partial response (PR) or stable disease (SD).
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