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NCT05683418 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors
A Phase 1 study of Endometrial Cancer and Bladder Cancer, sponsored by Totus Medicines.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
- 18
- Study locations
NCT05683418: Recruiting Phase 1 study of Endometrial Cancer and Bladder Cancer, sponsored by Totus Medicines.
NCT05683418 is a Phase 1 study of Endometrial Cancer and Bladder Cancer that is actively recruiting participants, run by Totus Medicines. The registered enrollment target is 241 participants, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (54% lower). The trial reports 18 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05683418, a Phase 1 study of Endometrial Cancer and Bladder Cancer, is actively recruiting participants, sponsored by Totus Medicines.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
- 18
- Study locations
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 |
What NCT05683418 shows while recruiting
NCT05683418 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (54% lower).
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.
NCT05683418 lists 18 locations in 8 states (Other, Massachusetts, California).
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.
What interventions are being tested in trial NCT05683418?
The interventions under investigation include: TOS-358 (DRUG).
Who is sponsoring clinical trial NCT05683418?
This trial is sponsored by Totus Medicines, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Endometrial Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05683418's enrollment target sits among peer trials
241 61st of 181 higher than 121 of 181 other Endometrial Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Endometrial Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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