drugset / Trial / NCT05270213

Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

NCT05270213

Phase 1 Recruiting 164 enrolled Riboscience, LLC.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

RBS2418 (investigational product) is a specific immune modulator, working through ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1), designed to lead to anti-tumor immunity by increasing endogenous 2'-3'-cyclic guanosine monophosphate-adenosine monophosphate (cGAMP) and adenosine triphosphate (ATP levels) and reducing adenosine production in the tumors. RBS2418 has the potential to be an important therapeutic option for subjects both as monotherapy and in combination with other cancer treatments including monotherapy and in combination with other cancer treatments including immunotherapy or chemotherapy. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or other approved anticancer therapies or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors. The phase 1a (dose escalation phase) has been completed. The Phase 1b expansion phase of the study has been increased in size and scope.

Timeline

Start
2022-07-11
Primary completion
2027-04
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject RBS2418 Small molecule 100 mg
Subject RBS2418 Small molecule 200 mg
Subject RBS2418 Small molecule 400 mg
Subject RBS2418 Small molecule 800 mg