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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.
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.
Primary Outcome
Frequency and severity, incidence of treatment-emergent and treatment-related adverse events using NCI-CTCAE v5.0
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2024-07-03 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06515470 shows while recruiting
NCT06515470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Breast 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 NCT06515470's enrollment target sits among peer trials
82 639th of 1224 higher than 582 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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.
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