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NCT03272334 · ClinicalTrials.gov registry record · Phase 1
Her2-BATS and Pembrolizumab in Metastatic Breast Cancer
A Phase 1 study of Metastatic Breast Cancer, sponsored by University of Virginia.
- Active
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 1
- Study location
NCT03272334 is a Phase 1 study of Metastatic Breast Cancer that is active but no longer recruiting, run by University of Virginia. The registered enrollment target is 22 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03272334, a Phase 1 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by University of Virginia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 1
- Study location
Study Summary
This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy. Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions.
Conditions Studied
Interventions
- DRUG HER2 BATs with Pembrolizumab
Study Locations (1)
Virginia
- Ashley Donihee - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2017-12-29 |
| Est. Completion | 2031-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03272334
The ClinicalTrials.gov registry entry for NCT03272334 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (89% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which HER2 BATs with Pembrolizumab is the first listed.
NCT03272334 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.
Frequently Asked Questions
What is clinical trial NCT03272334 about?
NCT03272334 is a clinical study titled "Her2-BATS and Pembrolizumab in Metastatic Breast Cancer". This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an addi...
What is the current status of trial NCT03272334?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2017-12-29. Estimated completion is 2031-01.
What conditions does trial NCT03272334 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT03272334?
The interventions under investigation include: HER2 BATs with Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03272334?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03272334 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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