A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
Recruiting now · Phase 1
Conditions studied: HR+/HER2-negative Breast Cancer
In brief
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: 1. Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2? 2. Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day? 3. Phase 1b: how safe and effective is TOS-358 when given with standard of care medicines for HR+HER2- metastatic breast cancer (fulvestrant and CDK4/6i)
Key facts
- Study ID
- NCT05683418
- Run by
- Totus Medicines
- People needed
- 241
- Starts
- 2023-02-15
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States (enrolling)
- Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
- Texas Oncology - Flower Mound — Flower Mound, Texas, United States (enrolling)
- Virginia Cancer Specialists — Fairfax, Virginia, United States (enrolling)
- NEXT Oncology - Hospital Quironsalud Barcelona - PPDS — Barcelona, Spain (enrolling)
- START Barcelona HM Nou Delfos — Barcelona, Spain (enrolling)
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona, Spain (enrolling)
- Hospital Clinico San Carlos — Madrid, Spain (enrolling)
- START MADRID Hospital Universitario Fundacion Jimenez Diaz - EDOS — Madrid, Spain (enrolling)
- START MADRID Hospital Universitario HM Sanchinarro - CIOCC — Madrid, Spain (enrolling)
- Clinica Universidad de Navarra — Pamplona, Spain (enrolling)
- NEXT Oncology - Hospital Quironsalud Madrid - PPDS — Pozuelo de Alarcón, Spain (enrolling)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (enrolling)
Full record on ClinicalTrials.gov
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