RBS2418 for Neoplasm Metastasis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neoplasm Metastasis+1 More
RBS2418 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Neoplasm Metastasis
  • Cancer, Advanced

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 1 Secondary · Reporting Duration: From 1- 21 days of the first cycle (each cycle is 21 days)

Day 30
Number of participants with treatment emergent Adverse events
Day 0 - 5
Area under the plasma concentration versus time curve (AUC)
Half-life (t1/2)
Optimal Biologically Active Dose
Peak plasma concentration (Cmax) of RBS2418
Day 21
Treatment emergent dose limiting toxicities (DLT)
nine weeks from first dose
Overall response rate (ORR) by RECIST

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Treatment Group B
1 of 3
Treatment Group A-1
1 of 3
Treatment Group A-2
1 of 3

Experimental Treatment

64 Total Participants · 3 Treatment Groups

Primary Treatment: RBS2418 · No Placebo Group · Phase 1

Treatment Group B
Drug
Experimental Group · 1 Intervention: RBS2418 · Intervention Types: Drug
Treatment Group A-1
Drug
Experimental Group · 1 Intervention: RBS2418 · Intervention Types: Drug
Treatment Group A-2
Drug
Experimental Group · 1 Intervention: RBS2418 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from 1- 21 days of the first cycle (each cycle is 21 days)

Who is running the clinical trial?

Oncobay Clinical, IncUNKNOWN
Riboscience, LLC.Lead Sponsor
Ildiko Csiki, MD PHDStudy DirectorRiboscience, LLC.

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to provide written informed consent for the study
You are 18 years of age or older.\n
You have histologically or cytologically confirmed cancer diagnosis based on pathology report.
You have measurable disease based on RECIST 1.1.
Subjects will be evaluated on a case-by-case basis for enrollment pending Sponsor consultation.
You are of childbearing potential and are not surgically sterilized or postmenopausal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 7th, 2021

Last Reviewed: November 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Tranquil Research100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%