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RBS2418 for Advanced, Metastatic Solid Tumors

This study is testing a new drug called RBS2418 for people with advanced, metastatic solid tumors (cancers that have spread). RBS2418 works by affecting your immune system to fight cancer. It may be given alone or with other approved cancer treatments like Pembrolizumab or standard-of-care therapies. The study has already completed an initial phase to find a safe dose and is now enrolling more people (about 140) to further check safety and how well it works. To join, you must be at least 18 years old, have received prior standard treatments, and have measurable cancer that has not responded to other therapies. The main goals are to see if RBS2418 is safe and to understand how your body processes the drug.

Study design
This is an interventional study with an unclear phase, planning to enroll 164 participants. It includes different treatment groups receiving RBS2418 alone or in combination with other approved therapies.
What's involved
You would need to provide written informed consent. An imaging scan is required at baseline, up to 28 days before starting treatment.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints for safety and drug levels are measured from 1-21 days of the first cycle (each cycle is 21 days) and Day 0-5 for drug levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05270213

Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Riboscience, LLC.
~164 participants
Updated 2025-12-19 on ClinicalTrials.gov
What's tested:RBS2418PembrolizumabOther approved anti-cancer therapy

At a glance

Recruiting sites
12 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment emergent dose limiting toxicities (DLT)
Measured over From 1- 21 days of the first cycle (each cycle is 21 days)
+5 more outcomes measured

Conditions

Advanced Cancer

Explore related trials

Solid Neoplasm

NCT05270213

Where you'd take part

This study runs at 14 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • American Oncology Partners of Maryland

    Bethesda, Marylandstudy coordinator listed

    Recruiting

  • Christiana Care Health Services

    Newark, Delawarestudy coordinator listed

    Recruiting

  • Honor Health Research Institute

    Scottsdale, Arizonastudy coordinator listed

    Recruiting

  • Ichan School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Marylandstudy coordinator listed

    Recruiting

  • NEXT Virigina

    Fairfax, Virginiastudy coordinator listed

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentuckystudy coordinator listed

    Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisianastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Riboscience Chief Medical Officer · STUDY_DIRECTOR · Riboscience, LLC.

Who to contact

Riboscience Clinical Trials
[email protected]
‪(415) 754-3182‬
Email the study team

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Eligibility criteria

Exclusion

Palliative radiotherapy for bone metastases or soft tissue lesions should be completed \> 7 days prior to baseline imaging
Hormone-replacement therapy or oral contraceptives
Subjects with Grade 2 neuropathy or Grade 2 alopecia 2. Subjects with evidence of rapid progression on prior therapy resulting in rapid clinical deterioration should be excluded from participation in the trial. 3. Currently participating and receiving trial therapy or has participated in a trial of an investigational agent and/or has used an investigational device within 28 days prior to Day 1. 4. Uncontrolled tumor-related pain 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures 6. Malignancies other than indications open for enrollment within 3 years prior to Day 1, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome, undergoing active surveillance or treatment-naïve for indolent tumors 7. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. 8. Known hypersensitivity allergy or contraindication to any investigational product components administered as part of the combination therapy. 9. Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). 10. History or any evidence of interstitial lung disease 11. Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment. 12. Active HIV requiring therapy and Uncontrolled HIV\*. HIV antibody testing recommended per investigator's clinical suspicion. 13. Active hepatitis B virus (HBV; hepatitis B surface antigen reactive) or active hepatitis C virus (HCV; qualitative RNA detected)\*; such as requiring active therapy (e.g. subjects with a history of HCV are eligible as long as viral RNA is below level of detection); testing recommended per investigator's clinical suspicion. 14. Severe infections within 4 weeks prior to enrollment, including, but not limited to, hospitalization for complications of infection, bacteremia, or the presence of any active infection requiring systemic therapy. 15. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 1 16. History or current evidence of any condition, therapy, or laboratory abnormality that in the opinion of the treating investigator might confound the results of the trial or interfere with the subject's participation for the full duration of the trial. 17. Subjects with:
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval of \> 480 milliseconds (ms) (CTCAE Grade 1) using Fridericia's QT correction formula
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
The use of concomitant medications that are known to prolong the QT/QTc interval unless there is evidence of the lack of QT/QTc interval prolongation at baseline. 18. Subjects with gastrointestinal disorders that may affect the absorption of the drug 19. Prior allogeneic stem cell or solid organ transplant. 20. 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 21. Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 22. Prisoner or subject who is compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infectious disease) illness. 23. Pregnant or lactating or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit through 120 days after the last dose of pembrolizumab and/or RBS2418.

What this trial measures

  • Treatment emergent dose limiting toxicities (DLT)From 1- 21 days of the first cycle (each cycle is 21 days)

    When more than 1 DLT occurs in ≤ 6 patients in a dosing cohort, MTD has been exceeded and no more patients are to be treated at that dose level. No DLT observed at the highest dose level in Part A. Part A has been completed.

  • Peak plasma concentration (Cmax) of RBS2418Day 0 - 5

    maximum plasma concentration of RBS2418

  • Area under the plasma concentration versus time curve (AUC)Day 0 - 5

    area under the curve for RBS2418

  • Optimal Biologically Active Dose (OBA)Day 0 - 5

    Dose at which Ctrough plasma concentration of RBS2418 equal to or higher than ENPP1 EC90 in human serum is achieved. All dose levels (100-800 mg BID) achieved the endpoint. Part A has been completed.

  • Half-life (t1/2)Day 0 - 5

    half-life of RBS2418

  • Number of participants with treatment emergent Adverse events30 days from last dose

    Adverse events, as graded by NCI CTCAE v5.0 including adverse events of special interest (AESI) classified by system organ class, preferred term, severity and relationship to drug