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NCT04727151 · ClinicalTrials.gov registry record · Phase 1
TAC T-cells for the Treatment of HER2-positive Solid Tumors
A Phase 1 study, sponsored by Triumvira Immunologics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04727151 is a Phase 1 study that was terminated before completion, run by Triumvira Immunologics. The registered enrollment target is 28 participants.
The verdict
NCT04727151, a Phase 1 study, was terminated before completion, sponsored by Triumvira Immunologics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor. This is an open-label, multicenter Phase 1/2 study that aims to establish safety, maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 as a monotherapy, and in combination with pembrolizumab, in subjects with HER2 positive gastric and gastroesophageal adenocarcinoma.
Interventions
- BIOLOGICAL TAC01-HER2
- BIOLOGICAL TAC01-HER2 plus pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2024-03-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04727151
The ClinicalTrials.gov registry entry for NCT04727151 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Triumvira Immunologics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TAC01-HER2 is the first listed.
NCT04727151 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04727151 about?
NCT04727151 is a clinical study titled "TAC T-cells for the Treatment of HER2-positive Solid Tumors". TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them ...
What is the current status of trial NCT04727151?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-04-19. Estimated completion is 2024-03-25.
What interventions are being tested in trial NCT04727151?
The interventions under investigation include: TAC01-HER2 (BIOLOGICAL), TAC01-HER2 plus pembrolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04727151?
This trial is sponsored by Triumvira Immunologics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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