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

Titre officiel

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

Sommaire:

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.

Description de l'essai

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).

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer