Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05270213
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2022-02-09
Brief Title:
Evaluation of RBS2418 in Subjects With Advanced Metastatic Solid Tumors
Sponsor:
Riboscience LLC
Organization:
Riboscience LLC
Study Overview
Official Title:
A First-In-Human Phase 1 ab Dose Escalation and Expansion Study to Evaluate RBS2418 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Unresectable Recurrent or Metastatic Tumors
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RBS2418 investigational product is a specific immune modulator working through ectonucleotide pyrophosphatasephosphodiesterase 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 checkpoint blockade This study is an open-label multi-site Phase 1a1b study of RBS2418 a selective ENPP1 inhibitor in combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable recurrent or metastatic tumors
Detailed Description:
In this Phase 1ab study subjects must have received standard of care SOC therapy for their advancedmetastatic tumors and subjects must have received have been intolerant to have been ineligible for or have declined all treatment known to confer significant clinical benefit Subjects must also have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors RECIST11 an Eastern Cooperative Oncology Group ECOG performance score of 0 1 or 2 and predicted life expectancy of greater than 3 months An imaging scan is required at baseline up to 28 days prior to treatment initiation Subjects are required to provide an adequate tumor tissue sample archival or fresh-tissue if no archival is available
Approximately 24 - 64 subjects will be enrolled and will receive therapy as part of their respective treatment groups ascending doses of RBS2418 of 100 mg 200 mg 400 mg and 800 mg BID as monotherapy or in combination with pembrolizumab 200 mg IV q3w The study consists of two 2 phases The first part of the study Part A is the dose escalation phase of the study and is planned to enroll up to 8 cohorts in total 3-6 subjects per cohort to receive RBS2418 as monotherapy or in combination with pembrolizumab to identify the fixed dose to be evaluated further in the expansion phase of the study Part B 20-40 subjects
A 33 design will be used to establish dose limiting toxicities DLT the maximum tolerated dose and the dose level of RBS2418 corresponding to an optimal biologically active dose to aid in the selection of the fixed expansion cohort dose
In all treatment arms treatment will continue until progressive disease PD unacceptable adverse events AEs intercurrent illness that prevents further administration of treatment investigators decision to withdraw the subject subject withdrawal of consent pregnancy of the subject noncompliance with study dosing or procedure requirements subject receiving approximately 2 years of RBS2418 monotherapy or in combination with pembrolizumab or administrative reasons requiring cessation of treatment
After the last dose of study drug each subject will be followed for 30 days for AE monitoring Serious adverse events SAEs will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy whichever is earlier
Approximately 24 - 64 subjects will be enrolled and will receive therapy as part of their respective treatment groups ascending doses of RBS2418 of 100 mg 200 mg 400 mg and 800 mg BID as monotherapy or in combination with pembrolizumab 200 mg IV q3w The study consists of two 2 phases The first part of the study Part A is the dose escalation phase of the study and is planned to enroll up to 8 cohorts in total 3-6 subjects per cohort to receive RBS2418 as monotherapy or in combination with pembrolizumab to identify the fixed dose to be evaluated further in the expansion phase of the study Part B 20-40 subjects
A 33 design will be used to establish dose limiting toxicities DLT the maximum tolerated dose and the dose level of RBS2418 corresponding to an optimal biologically active dose to aid in the selection of the fixed expansion cohort dose
In all treatment arms treatment will continue until progressive disease PD unacceptable adverse events AEs intercurrent illness that prevents further administration of treatment investigators decision to withdraw the subject subject withdrawal of consent pregnancy of the subject noncompliance with study dosing or procedure requirements subject receiving approximately 2 years of RBS2418 monotherapy or in combination with pembrolizumab or administrative reasons requiring cessation of treatment
After the last dose of study drug each subject will be followed for 30 days for AE monitoring Serious adverse events SAEs will be collected for 90 days after the end of treatment or for 30 days after the end of treatment if the subject initiates new anticancer therapy whichever is earlier
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None