A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
NCT05683418
This study is recruiting at 9 US sites in 7 states, according to its ClinicalTrials.gov record last updated .
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria. The main questions it aims to answer are: Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2? Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day?
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- HR+/HER2-negative Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 1
- Ages
- 18 years and older
- Sex
- Female
- Healthy volunteers
- Not accepted
- Sponsor
- Totus Medicines
- Last updated on ClinicalTrials.gov
- April 22, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Illinois · 1
- Northwestern Memorial Hospital · Chicago, IL
Massachusetts · 2
- Beth Israel Deaconess Medical Center · Boston, MA
- Dana-Farber Cancer Institute · Boston, MA
Nevada · 1
- Comprehensive Cancer Centers of Nevada · Las Vegas, NV
Pennsylvania · 1
- University of Pennsylvania · Philadelphia, PA
Tennessee · 2
- Sarah Cannon Cancer Center · Nashville, TN
- Vanderbilt-Ingram Cancer Center · Nashville, TN
Texas · 1
- Texas Oncology - Flower Mound · Flower Mound, TX
Virginia · 1
- Virginia Cancer Specialists · Fairfax, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.