Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
Sponsor: Totus Medicines
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: 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)
Official title: A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
241
Start Date
2023-02-15
Completion Date
2027-12
Last Updated
2026-04-22
Healthy Volunteers
No
Conditions
Interventions
TOS-358
Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor
Fulvestrant
Intramuscular SERD at standard doses
Palbociclib
CDK4/6 inhibitor at standard doses
Ribociclib
CDK4/6 inhibitor at standard doses
Locations (18)
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