TAC T-cells for the Treatment of HER2-positive Solid Tumours

Official Title

A Phase I/II Trial Investigating Safety and Efficacy of Autologous TAC T Cells Targeting HER2 in Relapsed or Refractory Solid Tumours

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, multicentre 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 in subjects with relapsed or refractory solid tumours.

Trial Description

Primary Outcome:

• Incidence of Treatment-Emergent Adverse Events

Secondary Outcome:

• Determine MTD or RP2D
• Determine expansion of TAC01-HER2
• Determine persistence of TAC01-HER2
• Evaluate Overall Response Rate (ORR)
• Evaluate Overall Survival (OS)

Phase I: Dose escalation in any 3+ HER2-positive solid tumour. Phase II: Dose expansion cohorts: 3+ HER2-positive breast cancer (a) and other solid tumours (b) 2+HER2-positive solid tumours (c).

View this trial on ClinicalTrials.gov