mTOR x Nav1.5 x Nav1.1 x DNA

The purpose of this study is to collect response and pharmacokinetic data on the oral administration of a cocktail combination of 4 drugs being developed for the indication of metastatic breast cancer.

This is a phase II single arm, open-label study of SM-88 used with methoxsalen, phenytoin, and sirolimus (MPS) in metastatic HR+/HER2- breast cancer. It is designed to determine efficacy, defined as the objective response rate (ORR) of this investigational treatment. It is hypothesized that SM-88 used with MPS will lead to significant anti-tumor responses with acceptable toxicities in patients with metastatic HR+/HER2- breast cancer.

Precision Promise is a multi-center, seamless Phase 2/3 platform trial designed to evaluate multiple regimens in metastatic pancreatic cancer.
Primary Objectives
To compare each investigational arm versus standard of care (SOC) for superiority in overall survival in first and/or second line metastatic ductal adenocarcinoma (metastatic pancreatic cancer) participants and determine which, if any, participants benefit from each investigational arm.
Secondary Objectives
To determine short and long-term safety signals of each investigational arm in metastatic pancreatic cancer participants vs. SOC.
To determine progression-free survival (PFS) for each investigational arm vs. SOC.
To determine rates of overall response, CR, and PR; duration of overall response, CR or PR (whichever occurs first).
To determine rates of clinical benefit; duration of clinical benefit.