drugset / Trial / NCT04727151
TAC T-cells for the Treatment of HER2-positive Solid Tumors
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-04-19
- Primary completion
- 2023-12-17
- Completion
- 2024-03-25
Outcome
Outcome not reported
Stopped: “Study terminated by Sponsor for commercial reasons”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | — | — |
| Subject | TAC01-HER2 | Cell therapy | — | Intravenous |
| Background | Bendamustine | Small molecule | — | — |
| Background | Clofarabine | Other / unclassified | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |