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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

Advanced Unresectable Hepatocellular Carcinoma

Over 18 Years
+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2025

See protocol details

Summary

Principal SponsorRiboscience, LLC.
Study ContactRiboscience Clinical Trials
Last updated: September 22, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual 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 
Principal SponsorRiboscience, LLC.
Study ContactRiboscience Clinical Trials
Last updated: September 22, 2025
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Advanced Unresectable Hepatocellular Carcinoma
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

Time in months from randomization until the first radiographic documentation of objective progression, as assessed using RECIST 1.1, or death from any cause.
Secondary Objectives

Time in months from the date of randomization to the date of death from any cause.

ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) during the study using RECIST 1.1, among those with measurable disease.

DOR is defined as time from initial response to disease progression or death.

DCR is defined as the percentage of participants who achieve a complete response (CR), partial response (PR) or stable disease (SD).

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 1 location
Suspended
Johns HopkinsBaltimore, United StatesSee the location
Recruiting soonOne Study Center