Recruiting
Phase 2

RBS2418 & STRIDE

Sponsor:

Riboscience, LLC.

Code:

NCT07175441

Conditions

Advanced Unresectable Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RBS2418

STRIDE (durvalumab + tremelimumab)

Study Details

Brief 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.

Conditions

Advanced Unresectable Hepatocellular Carcinoma

Study ID

NCT07175441

Start date

Apr 10, 2026

Status verified date

Apr, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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

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 and Locations

Central contacts

Riboscience Clinical Trials

415-754-3182clinicaltrials@riboscience.com

Locations

Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21218

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

START Dallas Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

More Information

Sponsor

Riboscience, LLC.

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • Advanced Unresectable Hepatocellular Carcinoma (HCC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Riboscience, LLC. on 2026-04-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.