RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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?

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

Quick Facts

Study Start:2023-02-15
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05683418

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Clinical Trials
CONTACT
Please e-mail
clinicaltrials@totusmedicines.com

Principal Investigator

Glenn Michelson, MD
STUDY_DIRECTOR
Totus Medicines

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Totus Medicines

  • Glenn Michelson, MD, STUDY_DIRECTOR, Totus Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-15
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-02-15
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

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