A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors

Description

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?

Conditions

Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Endometrial Cancer, HR+/HER2-negative Breast Cancer

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Study Overview

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Study Details

Study overview

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?

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

A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults with Select Solid Tumors

Condition
Squamous Cell Carcinoma of Head and Neck
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Los Angeles

University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

New Haven

Yale University, Yale Cancer Center, New Haven, Connecticut, United States, 06520

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Boston

Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Boston

Dana-Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Oklahoma City

Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Nashville

Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Totus Medicines,

    Glenn Michelson, MD, STUDY_DIRECTOR, Totus Medicines

    Study Record Dates

    2025-12