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.