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Immune Modulator

RBS2418 for Cancer

Phase 1
Recruiting
Research Sponsored by Riboscience, LLC.
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
Must not have
Received a live, attenuated vaccine within 28 days prior to enrollment/cohort assignment or anticipation that such a live attenuated vaccine will be required during the trial
History or any evidence of interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days from last dose
Awards & highlights

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 below
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I can care for myself and am up and about more than 50% of my waking hours.
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I am at least 18 years old.
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My cancer cannot be removed by surgery and has spread.
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I've had all standard treatments for my advanced cancer and there are no other options left.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 28 days and do not plan to during the trial.
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I have a history of lung scarring or damage.
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I have been treated for an autoimmune disease in the last 2 years.
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I haven't had any other cancers in the last 3 years.
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I have pain from my cancer that isn't relieved by treatment.
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I am on treatment for active HIV or my HIV is not under control.
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I am allergic to certain medications made in Chinese hamster ovary cells.
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I haven't had cancer treatment in the last 2 weeks.
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I frequently need procedures to remove excess fluid from my chest or abdomen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 - 5
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 - 5 for reporting.

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 more
Secondary outcome measures
Overall response rate (ORR) by RECIST

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cancer treatments work through various mechanisms to target and destroy cancer cells. Selective ENPP1 inhibitors like RBS2418 enhance anti-tumor immunity by increasing levels of cGAMP and ATP while reducing adenosine production, which helps activate immune responses against tumors. Other common treatments include chemotherapy, which kills rapidly dividing cells; targeted therapy, which blocks specific molecules involved in cancer growth and progression; immunotherapy, which boosts the body's immune system to fight cancer; and radiation therapy, which uses high-energy particles to destroy cancer cells. Understanding these mechanisms is crucial for cancer patients as it helps tailor treatments to their specific cancer type and improve outcomes by targeting the disease more effectively.
Co-targeting CDK4/6 and AKT with endocrine therapy prevents progression in CDK4/6 inhibitor and endocrine therapy-resistant breast cancer.Evaluating the efficacy of enzalutamide and the development of resistance in a preclinical mouse model of type-I endometrial carcinoma.Potential molecular targets for Ewing's sarcoma therapy.

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

RBS2418 (Immune Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05270213 — Phase 1
Cancer Research Study Groups: Treatment Group B, Treatment Group A-1, Treatment Group A-2
Cancer Clinical Trial 2023: RBS2418 Highlights & Side Effects. Trial Name: NCT05270213 — Phase 1
RBS2418 (Immune Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05270213 — Phase 1
~22 spots leftby Sep 2025