Evaluation of RBS2418 in Subjects With Advanced, Metastatic Solid Tumors

The dose escalation phase (Part A) of this Phase 1a/1b study has been completed (n=24 study participants). Based on safety and preliminary activity data, we have expanded the size and scope of the dose expansion phase (Part B), which will include treatment groups receiving RBS2418 at selected dose levels. These doses will be administered either as monotherapy or in combination with approved anti-cancer therapies, including pembrolizumab (200 mg IV every 3 weeks), or other standard-of-care therapies at the discretion of the site principal investigator (PI). Part B is enrolling approximately 140 subjects to further assess safety, tolerability, and preliminary efficacy at selected doses in expansion cohorts. 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). In all treatment arms, treatment continues 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 combination therapy, 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