A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
Recruiting · NCT05683418 · Interventional (participants receive a specific treatment) · Lead sponsor: Totus Medicines
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
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
Where it is running
18 locations listed across 7 US states.
- Northwestern Memorial Hospital - Chicago, Illinois, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Comprehensive Cancer Centers of Nevada - Las Vegas, Nevada, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Sarah Cannon Cancer Center - Nashville, Tennessee, United States
- Vanderbilt-Ingram Cancer Center - Nashville, Tennessee, United States
- Texas Oncology - Flower Mound - Flower Mound, Texas, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- NEXT Oncology - Hospital Quironsalud Barcelona - PPDS - Barcelona, Spain
- START Barcelona HM Nou Delfos - Barcelona, Spain
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON - Barcelona, Spain
- Hospital Clinico San Carlos - Madrid, Spain
- START MADRID Hospital Universitario Fundacion Jimenez Diaz - EDOS - Madrid, Spain
- START MADRID Hospital Universitario HM Sanchinarro - CIOCC - Madrid, Spain
- Clinica Universidad de Navarra - Pamplona, Spain
- NEXT Oncology - Hospital Quironsalud Madrid - PPDS - Pozuelo de Alarcón, Spain
- Hospital Clinico Universitario de Valencia - Valencia, Spain