Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma
NCT ID: NCT07175441
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2026-01-31
2027-08-31
Brief Summary
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Detailed Description
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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 earlier.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: RBS2418, 200mg BID, plus STRIDE
RBS2418 200 mg PO, BID in combination with STRIDE regimen
RBS2418
RBS2418 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)
STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
Arm B: RBS2418, 800mg BID, plus STRIDE
RBS2418 800 mg PO, BID in combination with STRIDE regimen
RBS2418
RBS2418 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)
STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
Arm C: STRIDE alone (control)
STRIDE regimen
STRIDE (durvalumab + tremelimumab)
STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
Interventions
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RBS2418
RBS2418 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)
STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Riboscience, LLC.
INDUSTRY
Responsible Party
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Locations
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Johns Hopkins
Baltimore, Maryland, United States
Countries
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Central Contacts
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Other Identifiers
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RBS2418-2002
Identifier Type: -
Identifier Source: org_study_id