A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors
NCT ID: NCT05683418
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
241 participants
INTERVENTIONAL
2023-02-15
2026-12-31
Brief Summary
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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?
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Detailed Description
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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, cancer of the bladder, or endometrial cancer with known PIK3CA mutations or amplifications and who meet all of the eligibility criteria will be enrolled in 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
Part 1 (multiple ascending doses, QD or BID): locally advanced, recurrent or metastatic HR+ breast, endometrial, urothelial or squamous cell carcinoma of the head and neck, with PIK3CA mutation per local assessment; Part 2 (RP2D determined in Part 1) Patients with locally advanced, recurrent or metastatic HR+ breast cancer with PIK3CA mutation per local assessment will be enrolled protocol defined groups.
TREATMENT
NONE
Study Groups
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TOS-358 Single Agent Arm
Multiple doses of TOS-358 for oral administration.
TOS-358
Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor
Interventions
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TOS-358
Covalent Phosphoinositide-3-Kinase (PI3K)-alpha Inhibitor
Eligibility Criteria
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Inclusion Criteria
* 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 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
Exclusion Criteria
* For non-breast cancer: prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway,
* Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2 requiring antihyperglycemic medication
* Known active central nervous system (CNS) metastases.
18 Years
ALL
No
Sponsors
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Totus Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Zelanna Goldberg, MD
Role: STUDY_DIRECTOR
Totus Medicines
Locations
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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 Alarcón, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-505346-26-01
Identifier Type: CTIS
Identifier Source: secondary_id
TOS-358-001
Identifier Type: -
Identifier Source: org_study_id
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