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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: Clinical Trial Phase 1 study, sponsored by Triumvira Immunologics.
NCT04727151 is a Phase 1 study that was terminated before completion, run by Triumvira Immunologics. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT is defined as: * Grade 4 or 5 events determined by the Investigator to be related to the investigational product, with the exception of Grade 4 laboratory abnormalities that are rapidly reversible or correctable without substantial safety concerns. * Grade ≥3 TAC T cell-associated acute infusion reactions persisting for ≥24 hours * Grade ≥3 TAC T cell-associated CRS or neurotoxicity persisting for ≥72 hours * Grade ≥3 cardiovascular or pulmonary toxicity persisting for ≥72 hours * Grade ≥
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 |
Why NCT04727151 stopped before completion
NCT04727151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which TAC01-HER2 is the first listed.
NCT04727151 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04727151's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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