RecruitingPhase 1NCT05683418

A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer

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

Sponsor

Totus Medicines

Enrollment

241 participants

Start Date

Feb 15, 2023

Study Type

INTERVENTIONAL

Conditions

HR+/HER2-negative Breast Cancer

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)

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called TOS-358 in adults with certain types of advanced cancer — including hormone receptor-positive breast cancer, head and neck cancer, bladder cancer, or endometrial cancer — that have a specific genetic change called a PIK3CA mutation. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic breast cancer (hormone receptor positive, HER2 negative), head and neck cancer, bladder cancer, or endometrial cancer that cannot be cured - Your tumor has been tested and found to have a PIK3CA mutation or amplification - Your cancer can be measured on scans - You are in reasonably good physical health (ECOG 0–1) - Your blood sugar and HbA1c levels are within acceptable ranges - You have adequate kidney, liver, and bone marrow function **You may NOT be eligible if...** - You recently received other cancer treatments (some exceptions apply) - You have previously been treated with PI3K, AKT, or mTOR inhibitors (for non-breast cancers) - You have poorly controlled diabetes - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTOS-358

Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor

DRUGFulvestrant

Intramuscular SERD at standard doses

DRUGPalbociclib

CDK4/6 inhibitor at standard doses

DRUGRibociclib

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05683418

Related Trials

Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer

NCT0545561910 locations