Brief Title: TOS-358 in Adults With Select Solid Tumors

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Determine the rate of dose-limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: First 21 days of treatment

Primary Outcome 2 - Measure: Incidence and severity of adverse events (AEs) and specific laboratory abnormalities graded according to NCI CTCAE v5

Primary Outcome 2 - Timeframe: Start of treatment to 30 days after last dose

CONDITION

• HR+/HER2-negative Breast Cancer

ELIGIBILITY

Key Inclusion Criteria
* Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer

- * Up to 3 prior lines of therapy for metastatic disease

- * Willing and able to provide written informed consent for this study

- * Adults ≥ 18 years old at time of consent

- * Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test

- * Measurable or evaluable disease by RECIST 1.1

- * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- * Life expectancy ≥ 6 months, as determined by the investigator

- * Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product

- * Fasting plasma glucose <= 140 mg/dL AND hemoglobin A1c (HbA1c) <= 7.0% - * Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test
Key Exclusion Criteria
* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2

- * Known active central nervous system (CNS) metastases

- * PTEN mutations

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Zelanna Goldberg, MD

Role: Study Director

Affiliation: Totus Medicines

Overall Contact

Name: Clinical Trials

Phone: Please e-mail

Email: [email protected]

LOCATION