A Phase 2a, Multicenter, Randomized, Open-Label Study to Assess the Efficacy, Safety, and Tolerability of RBS2418 in Combination With Tremelimumab Plus Durvalumab for Participants With Advanced Unresectable Hepatocellular Carcinoma

Study Identifier:
RBS2418-2002
CT.gov Identifier:
NCT07175441
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Liver
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: ACTIVE COMPARATOR: Arm A: RBS2418, 200mg BID, plus STRIDE
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  • Drug: RBS2418 200 mg PO, BID in combination with STRIDE regimen
  • Drug: Drug: RBS2418
  • Drug: 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.
  • Drug: Drug: STRIDE (durvalumab + tremelimumab)
  • Drug: STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks
  • Drug: ACTIVE COMPARATOR: Arm B: RBS2418, 800mg BID, plus STRIDE
  • Drug: RBS2418 800 mg PO, BID in combination with STRIDE regimen
  • Drug: ACTIVE COMPARATOR: Arm C: STRIDE alone (control)
  • Drug: STRIDE regimen
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Recruiting
    Condition(s) Treated at Site
    Liver