Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors
NCT05683418 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DRUG TOS-358
Study Locations (18)
Other
- NEXT Oncology - Hospital Quironsalud Barcelona - PPDS — Barcelona
- START Barcelona HM Nou Delfos — Barcelona
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON — Barcelona
- Hospital Clinico San Carlos — Madrid
- START MADRID Hospital Universitario Fundacion Jimenez Diaz - EDOS — Madrid
- START MADRID Hospital Universitario HM Sanchinarro - CIOCC — Madrid
- Clinica Universidad de Navarra — Pamplona
- NEXT Oncology - Hospital Quironsalud Madrid - PPDS — Pozuelo de Alarcón
- Hospital Clinico Universitario de Valencia — Valencia
Massachusetts
- Massachusetts General Hospital Cancer Center — Boston
- Beth Israel Deaconess Medical Center — Boston
- Dana-Farber Cancer Institute — Boston
California
- University of Southern California, Norris Comprehensive Cancer Center — Los Angeles
Illinois
- Northwestern Memorial Hospital — Chicago
Oklahoma
- Stephenson Cancer Center — Oklahoma City
Pennsylvania
- University of Pennsylvania — Philadelphia
Tennessee
- Vanderbilt-Ingram Cancer Center — Nashville
Virginia
- Virginia Cancer Specialists, PC — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2023-02-15 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05683418
The ClinicalTrials.gov registry entry for NCT05683418 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Totus Medicines, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 1 intervention — of which TOS-358 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05683418 reports 18 study locations spanning 8 distinct geographic areas — top geographies include Other, Massachusetts, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05683418 about?
NCT05683418 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors". 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 diffe...
What is the current status of trial NCT05683418?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2023-02-15. Estimated completion is 2026-12.
What conditions does trial NCT05683418 study?
This clinical trial studies the following conditions: Endometrial Cancer, Bladder Cancer, Squamous Cell Carcinoma of Head and Neck, HR+/HER2-negative Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05683418?
The interventions under investigation include: TOS-358 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05683418?
This trial is sponsored by Totus Medicines, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05683418 being conducted?
This trial has 18 study locations across California, Illinois, Massachusetts, Oklahoma, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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