Recruiting

RBS2418, Tremelimumab, and Durvalumab for Advanced Unresectable Hepatocellular Carcinoma

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What is being tested

RBS2418

+ STRIDE (durvalumab + tremelimumab)

Drug
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorRiboscience, LLC.
Study ContactRiboscience Clinical Trials
Last updated: January 17, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on testing a combination of medications for people with advanced liver cancer, specifically those whose cancer cannot be surgically removed. The aim is to see how well the new drug RBS2418 works when used with other drugs, Tremelimumab and Durvalumab, which are already given as a standard treatment. Participants need to have a certain level of physical health and a life expectancy of at least 12 weeks to join the study. This research is important because it could lead to better treatment options for those with advanced liver cancer, who currently have limited choices. Participants in the study will be divided into groups, with up to 220 people involved. Some will receive RBS2418 at different doses along with the standard treatment, while others will get the standard treatment alone. The treatment is given in cycles that last 28 days and can continue for up to two years, or until the cancer progresses, the participant leaves the study, or the study ends. Researchers will closely monitor any side effects, noting their severity according to standard guidelines. Side effects will be tracked for up to 30 days after the last dose of the study drug, and serious side effects will be monitored for up to 90 days after stopping the medication.

Official TitleA 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 
NCT07175441
Principal SponsorRiboscience, LLC.
Study ContactRiboscience Clinical Trials
Last updated: January 17, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

220 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

3 inclusion criteria required to participate
At least 18 years of age on the day of signing informed consent.

Male and female participants with advanced, unresectable HCC who are eligible to receive STRIDE regimen as first line therapy.

Willing to submit a pre-treatment tissue sample (archival or fresh tissue if archival is not available).

4 exclusion criteria prevent from participating
BCLC stage D disease at the time of screening or prior to first dose of RBS2418.

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.

Eligible for curative treatments (e.g., surgical resection, liver transplantation, or local ablation).

Evidence of rapid progression on prior therapy resulting in rapid clinical deterioration.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
RBS2418 200 mg PO, BID in combination with STRIDE regimen

Group II

Active Comparator
RBS2418 800 mg PO, BID in combination with STRIDE regimen

Group III

Active Comparator
STRIDE regimen

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Johns Hopkins

Baltimore, United StatesSee the location
Recruiting

START Dallas Fort Worth

Fort Worth, United States
Recruiting
2 Study Centers