Clinical trial · Interventional
Evaluation of RBS2418 in Combination With Tremelimumab Plus Durvalumab in Participants With Advanced Unresectable Hepatocellular Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Unresectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RBS2418 | Drug | — | UNRESOLVED |
| STRIDE (durvalumab + tremelimumab) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm A: RBS2418, 200mg BID, plus STRIDE
- description
- RBS2418 200 mg PO, BID in combination with STRIDE regimen
- interventionNames
- Drug: RBS2418
- Drug: STRIDE (durvalumab + tremelimumab)
- type
- ACTIVE_COMPARATOR
- label
- Arm B: RBS2418, 800mg BID, plus STRIDE
- description
- RBS2418 800 mg PO, BID in combination with STRIDE regimen
- interventionNames
- Drug: RBS2418
- Drug: STRIDE (durvalumab + tremelimumab)
- type
- ACTIVE_COMPARATOR
- label
- Arm C: STRIDE alone (control)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available