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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 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.

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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

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

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

FieldValue
Enrollment Target 241 participants
Start Date 2023-02-15
Est. Completion 2026-12
Phase Phase 1

Sponsor

Totus Medicines

1 total trials

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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, categorized as Phase 1. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 523-participant average among 181 other Endometrial Cancer trials with a reported enrollment target (54% lower). The listed sponsor is Totus Medicines, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 18 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.