Evaluating TOS-358 for safety in adults with certain solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and tolerability of TOS-358 in adults diagnosed with specific solid tumors, including HR+/HER2-negative breast cancer, squamous cell carcinoma of the head and neck, urothelial carcinoma, and endometrial cancer. The study is divided into two parts: a dose-finding phase to determine the maximum tolerated dose and a dose expansion phase to evaluate safety in tumor-specific cohorts. Participants will receive TOS-358 orally, either once or twice daily, until disease progression or unacceptable toxicity occurs.

Why it matters

Who can join: the full rules

Key Inclusion Criteria

* Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
* Up to 3 prior lines of therapy for metastatic disease
* Willing and able to provide written informed consent for this study
* Adults ≥ 18 years old at time of consent
* Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test
* Measurable or evaluable disease by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy ≥ 6 months, as determined by the investigator
* Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product
* Fasting plasma glucose \<= 140 mg/dL AND hemoglobin A1c (HbA1c) \<= 7.0%
* Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test

Key Exclusion Criteria

* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2
* Known active central nervous system (CNS) metastases
* PTEN mutations

Where it's running

• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Dana-Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Comprehensive Cancer Centers of Nevada
  Las Vegas, Nevada, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Sarah Cannon Cancer Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials
• Email: clinicaltrials@totusmedicines.com
• Phone: Please e-mail

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.