A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
- Conditions
- Squamous Cell Carcinoma of Head and NeckUrothelial CarcinomaEndometrial CancerHR+/HER2-negative Breast Cancer
- Interventions
- Registration Number
- NCT05683418
- Lead Sponsor
- Totus Medicines
- Brief Summary
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day?
- Detailed Description
This study will be conducted in two parts: a dose finding portion to determine the maximum tolerated dose and recommended phase 2 dose (RP2D) of TOS-358 administered orally on once a day (QD) and twice daily (BID) schedules, and a dose expansion portion to evaluate safety and tolerability in tumor-specific cohorts administered TOS-358 at the recommended phase 2 dose and schedule.
Adult subjects with histologically confirmed diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2) negative breast cancer, squamous cell carcinoma of the head and neck, urothelial cancer, or endometrial cancer with known PIK3CA mutations or amplifications (as determined at a College of American Pathologists/clinical laboratory improvement amendments \[CAP/CLIA\]-certified or equivalently accredited diagnostic laboratory using a validated test), who meet all of the eligibility criteria will be enrolled in the Phase 1 portion of the study.
In the dose finding portion of the study, TOS-358 will be evaluated as a single-agent at multiple dose levels administered orally until disease progression, unacceptable toxicity, or until meeting any other reason for discontinuation as specified in the protocol.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 241
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TOS-358 Single Agent Arm TOS-358 Multiple doses of TOS-358 for oral administration.
- Primary Outcome Measures
Name Time Method Determine the rate of dose-limiting toxicities (DLTs) First 21 days of treatment Incidence and severity of adverse events (AEs) and specific laboratory abnormalities graded according to NCI CTCAE v5 Start of treatment to 30 days after last dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
City of Hope
🇺🇸Duarte, California, United States
University of Southern California, Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Stephenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Virginia Cancer Specialists, PC
🇺🇸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 Alarcon, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain