Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

RBS2418 will be administered orally at 200 mg two times per day (BID).

RBS2418

Bertrand Tuan, MD

This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.

Given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with RBS2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. Furthermore, patient's tumor has been shown to express ENPP1, the protein targeted by RBS2418

Expanded Access RBS2418 Treatment

Expanded Access to RBS2418 for an Individual Patient With Pancreatic Cancer

Dr. Bertrand Tuan

Riboscience, LLC.

Symptoms and General Pathology

Neoplasm Metastasis

Recurrence

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

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

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.

RBS2418 is a potent and selective small molecule inhibitor of ectonucleotide pyrophosphatase/phosphodiesterase I (ENPP1). RBS2418 as monotherapy potentially can have an activating effect on the anti-tumor innate immune response and lead to anti-tumor responses in adult subjects with advanced or metastatic tumors.

Riboscience Clinical Trials

Riboscience Chief Medical Officer

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 checkpoint blockade. This study is an open-label, multi-site Phase 1a/1b study of RBS2418, a selective ENPP1 inhibitor, in combination with pembrolizumab or as a monotherapy in subjects with advanced unresectable, recurrent or metastatic tumors.

In this Phase 1a/b study, subjects must have received standard of care (SOC) therapy for their advanced/metastatic 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 (RECIST1.1), 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 "3+3" 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, investigator's 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

A "3+3" design will be used to establish dose limiting toxicities (DLT), the maximum tolerated dose (MTD, if applicable) and the dose level of RBS2418 as monotherapy and in combination with pembrolizumab corresponding to an optimal biologically active dose to aid in the selection of the fixed expansion cohort dose. There will be three treatment groups for this study:

* Treatment Group A-1: RBS2418 Dose Escalation (Monotherapy)
* Treatment Group A-2: RBS2418 Dose Escalation plus Pembrolizumab (Combination Therapy)
* Treatment Group B: RBS2418 as Monotherapy or RBS2418 plus Pembrolizumab Expansion Phase

Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

A First-In-Human, Phase 1 a/b Dose Escalation and Expansion Study to Evaluate RBS2418 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Unresectable, Recurrent or Metastatic Tumors

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

Plasma concentration of RBS2418 that corresponds to EC90

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

Beginning with screening, all imaging assessments will be evaluated using RECIST 1.1. On- study imaging assessments will be performed Q9W. RECIST 1.1 will be used by the site for treatment decisions until the first radiographic evidence of PD.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expanded Access RBS2418 Treatment	NCT05683470	Expanded Access...	RBS2418	-	Riboscience, LLC.
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors	NCT05270213	Advanced Cancer	RBS2418	18 Years -	Riboscience, LLC.
Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors	NCT05270213	Advanced Cancer	RBS2418	18 Years -	Riboscience, LLC.

Spots Global Cancer Trial Database for rbs2418

Every month we try and update this database with for rbs2418 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rbs2418

Every month we try and update this database with for rbs2418 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rbs2418 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.