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NCT05573126 · ClinicalTrials.gov registry record · Phase 1
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
A Phase 1 study of Metastatic Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Ellipses Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
- 14
- Study locations
NCT05573126: Recruiting Phase 1 study of Metastatic Breast Cancer and Hormone Receptor-Positive Breast Cancer, sponsored by Ellipses Pharma.
NCT05573126 is a Phase 1 study of Metastatic Breast Cancer and Hormone Receptor-Positive Breast Cancer that is actively recruiting participants, run by Ellipses Pharma. The registered enrollment target is 95 participants, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (53% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05573126, a Phase 1 study of Metastatic Breast Cancer and Hormone Receptor-Positive Breast Cancer, is actively recruiting participants, sponsored by Ellipses Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
- 14
- Study locations
Study Summary
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
Primary Outcome
Module A
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Fulvestrant
- DRUG Abemaciclib
- DRUG Elacestrant
- DRUG EP0062
Study Locations (14)
Other
- Hospital Universitari Vall d'Hebron (VHIO) - Barcelona
- Hospital Universitario Ramón y Cajal - Madrid
- NEXT Oncology Hospital Quironsalud - Madrid
- The Clatterbridge Cancer Centre - Liverpool
Connecticut
- Yale School of Medicine - New Haven
Florida
- Moffitt Cancer Center - Tampa
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Henry Ford Hospital - Detroit
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- Texas Oncology Baylor University Medical Center - Dallas
Virginia
- Virginia Cancer Specialists - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2028-02 |
| Phase | Phase 1 |
What NCT05573126 shows while recruiting
NCT05573126 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 204-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (53% lower).
The record links to 3 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Everolimus is the first listed.
NCT05573126 lists 14 locations in 11 states (Other, Connecticut, Florida).
Frequently Asked Questions
What is clinical trial NCT05573126 about?
NCT05573126 is a clinical study titled "Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer". The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
What is the current status of trial NCT05573126?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2023-01-11. Estimated completion is 2028-02.
What conditions does trial NCT05573126 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, Hormone Receptor-Positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer.
What interventions are being tested in trial NCT05573126?
The interventions under investigation include: Everolimus (DRUG), Fulvestrant (DRUG), Abemaciclib (DRUG), Elacestrant (DRUG), EP0062 (DRUG).
Who is sponsoring clinical trial NCT05573126?
This trial is sponsored by Ellipses Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05573126 being conducted?
This trial has 14 study locations across Connecticut, Florida, Massachusetts, Michigan, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05573126's enrollment target sits among peer trials
95 64th of 139 higher than 76 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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