Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a performance status of 0, 1 or 2 using the ECOG Performance Scale within 14 days of first dose of study drug
Be 18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days from last dose
Awards & highlights
Study Summary
This trial is testing a new cancer drug, RBS2418, to see if it is effective at treating tumors. The drug works by increasing immunity and reducing adenosine production in tumors. This study is Phase 1a/1b, which means it is the first time the drug is being tested in humans. The study is open-label, meaning all participants will receive the drug, and it is multi-site, meaning it will take place at more than one location.
Who is the study for?
Adults with advanced, inoperable or metastatic tumors who've tried all standard treatments without success can join. They must have a life expectancy of at least 3 months, be able to perform daily activities (with some limitations), and provide consent. Pregnant women are excluded, as well as those with severe allergies to certain drugs or uncontrolled cancer symptoms.Check my eligibility
What is being tested?
RBS2418 is being tested for its ability to boost the body's immune response against tumors by affecting cellular compounds like cGAMP and ATP. This trial will explore RBS2418 alone or combined with pembrolizumab in patients whose cancers haven't responded to standard care.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related responses, fatigue, digestive issues, blood abnormalities and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
I am at least 18 years old.
Select...
My cancer cannot be removed by surgery and has spread.
Select...
I've had all standard treatments for my advanced cancer and there are no other options left.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 - 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 - 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the plasma concentration versus time curve (AUC)
Half-life (t1/2)
Number of participants with treatment emergent Adverse events
+3 moreSecondary outcome measures
Overall response rate (ORR) by RECIST
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
3Treatment groups
Experimental Treatment
Group I: Treatment Group BExperimental Treatment1 Intervention
After dose escalation phase is completed in both monotherapy and combination therapy setting (A-1 and A-2), an expansion treatment group will be enrolled, and subjects (n=20- 40) will be treated with a fixed dose of RBS2418 to be selected by the Sponsor in consultation with the SRC and after reviewing the totality of the dose escalation data both as monotherapy and combination therapy.
Group II: Treatment Group A-2Experimental Treatment1 Intervention
For Treatment Group A-2, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418 in combination with pembrolizumab 200 mg IV (administered on Day 1 and every 3 weeks). Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID
Group III: Treatment Group A-1Experimental Treatment1 Intervention
For Treatment Group A-1, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418. Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID
Find a Location
Who is running the clinical trial?
Riboscience, LLC.Lead Sponsor
1 Previous Clinical Trials
Oncobay Clinical, IncUNKNOWN
Riboscience Chief Medical OfficerStudy DirectorRiboscience, LLC.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on treatment for active HIV or my HIV is not under control.My blood, kidney, liver, and clotting tests are all within normal ranges.I can care for myself and am up and about more than 50% of my waking hours.I haven't taken any immune system affecting drugs in the last 4 weeks or before.I agree to provide tissue samples before and during treatment for testing.I have not received a live vaccine in the last 28 days and do not plan to during the trial.I've had all standard treatments for my advanced cancer and there are no other options left.I have a history of lung scarring or damage.I have been treated for an autoimmune disease in the last 2 years.I haven't taken any immune-weakening drugs in the last 2 weeks.I am at least 18 years old.I haven't had any other cancers in the last 3 years.My cancer cannot be removed by surgery and has spread.I have not taken any antibiotics by mouth or IV in the last 2 weeks.I have pain from my cancer that isn't relieved by treatment.I am allergic to certain medications made in Chinese hamster ovary cells.I have not had a severe infection in the last 4 weeks.I haven't had cancer treatment in the last 2 weeks.I frequently need procedures to remove excess fluid from my chest or abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group B
- Group 2: Treatment Group A-1
- Group 3: Treatment Group A-2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are taking part in this particular research project?
"To complete this trial, 64 patients that meet the predetermined qualifications must participate. Participating sites include Ichan School of Medicine at Mount Sinai in New york City and American Oncology Partners of Maryland, PA located in Bethesda."
Answered by AI
Does RBS2418 present any health risks for individuals?
"As this is a Phase 1 trial, which means there exist limited evidence of safety and efficacy, RBS2418 was assigned a score of one."
Answered by AI
How widespread is the implementation of this trial across various health care centers?
"This trial is actively recruiting from 9 different medical centres like the Ichan School of Medicine at Mount Sinai in New york, American Oncology Partners Maryland PA in Bethesda and UCLA Hematology/Oncology - Santa Monica. Additionally, 6 more sites are currently participating."
Answered by AI
Are there any vacancies available in this research experiment?
"Affirmative. The clinical trial registry reveals that this study is still open to enrolment, with its initial posting occurring on April 19th 2022 and the latest update happening on October 11th 2022. 64 participants are currently being recruited across 9 medical sites."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Tranquil Research
Ohio State University
What portion of applicants met pre-screening criteria?
Met criteria
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger