Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma

Conditions

• Advanced Unresectable Hepatocellular Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• STRIDE (durvalumab + tremelimumab) — DRUG
  STRIDE: Tremelimumab 300 mg IV (Cycle 1 Day 1 only) Plus Durvalumab 1500 mg IV every 4 weeks

Study Details

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.

Key Dates

Start date

Apr 10, 2026

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Aug 31, 2027

Study Design

Enrollment

220 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A: RBS2418, 200mg BID, plus STRIDE
  RBS2418 200 mg PO, BID in combination with STRIDE regimen
• Active Comparator: Arm B: RBS2418, 800mg BID, plus STRIDE
  RBS2418 800 mg PO, BID in combination with STRIDE regimen
• Active Comparator: Arm C: STRIDE alone (control)
  STRIDE regimen

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomization until the first radiographic documentation of objective progression or death from any cause, assessed up to 2 years. ]

Central Contacts

• Riboscience Clinical Trials
  415-754-3182
  [email protected]

Locations (4)

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