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NCT06515470 · ClinicalTrials.gov registry record · Phase 1

Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by Biotheryx.

Recruiting
Registry status
Phase 1
Development phase
82
Enrollment target
6
Study locations

NCT06515470: Recruiting Phase 1 study of Breast Cancer, sponsored by Biotheryx.

NCT06515470 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Biotheryx. The registered enrollment target is 82 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06515470, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Biotheryx.

RECRUITING
Registry status
Phase 1
Development phase
82 participants
Enrollment target
6
Study locations

Study Summary

The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The study includes a dose escalation part (Part A) where small groups of participants will receive increasing doses of BTX-9341 or BTX-9341 + fulvestrant followed by a dose expansion part (Part B) where participants will receive the dose of BTX-9341 selected in Part A + fulvestrant.

Conditions Studied

Breast Cancer

Interventions

  • DRUG Fulvestrant
  • DRUG BTX-9341

Study Locations (6)

Texas

  • Biotheryx Investigative Site - Houston
  • Biotheryx Investigative Site - San Antonio

Minnesota

  • Biotheryx Investigative Site - Rochester

Nebraska

  • Biotheryx Investigative Site - Omaha

Utah

  • Biotheryx Investigative Site - West Valley City

Virginia

  • Biotheryx Investigative Site - Fairfax

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2024-07-03
Est. Completion 2027-12-31
Phase Phase 1

Sponsor

Biotheryx

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06515470

The ClinicalTrials.gov registry entry for NCT06515470 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Biotheryx, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant is the first listed.

NCT06515470 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Texas, Minnesota, Nebraska.

Frequently Asked Questions

What is clinical trial NCT06515470 about?

NCT06515470 is a clinical study titled "Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTX-9341 in Advanced and/or Metastatic Breast Cancer". The purpose of this study is to test BTX-9341 alone or in combination with fulvestrant (a currently marketed medication for breast cancer) in participants with advanced and/or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer. The stud...

What is the current status of trial NCT06515470?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2024-07-03. Estimated completion is 2027-12-31.

What conditions does trial NCT06515470 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT06515470?

The interventions under investigation include: Fulvestrant (DRUG), BTX-9341 (DRUG).

Who is sponsoring clinical trial NCT06515470?

This trial is sponsored by Biotheryx, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06515470 being conducted?

This trial has 6 study locations across Minnesota, Nebraska, Texas, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Read our methodology - how this data is sourced, computed, and verified.
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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, the data changelog, or report a data error.