An official website of the United States government
Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma
Trial Status: active
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.
Inclusion Criteria
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).
Exclusion Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07175441.
Locations matching your search criteria
United States
Florida
Jacksonville
Mayo Clinic in Florida
Status: Approved
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
In this Phase 2a study, participants must have advanced, unresectable HCC confirmed by
radiology, histology or cytology. Participants must be eligible to receive the STRIDE
regimen as first line therapy. Participants must have measurable disease per RECIST 1.1,
an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2, and
predicted life expectancy of at least 12 weeks.
Up to approximately 220 participants will be enrolled and will receive therapy as part of
their respective treatment group. Participants will receive study treatment of RBS2418 at
two different dose levels (200mg and 800mg) twice daily in combination with STRIDE or
STRIDE alone with a treatment period consisting of 28-day cycles up to two years or until
there is progressive disease, death, withdrawal, or study completion, whichever comes
first.
Adverse Events (AEs) will be monitored throughout the study and graded in severity
according to the guidelines outlined in the NCI CTCAE v5.0. AEs will be collected until
up to 30 days after the last dose of RBS2418 or until resolution, whichever comes first.
SAEs will be collected for 90 days after the last dose of RBS2418, or if the participant
initiates new anti-cancer therapy, then 30 days after the RBS2418 last dose, whichever is
