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TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)

Trial Profile

TACTI-002 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Phase II Study in Patients With Previously Untreated Unresectable or Metastatic Non-small Cell Lung Cancer (NSCLC), or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic Squamous Head and Neck Cancer (HNSCC) Receiving the Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) in Combination With Pembrolizumab (PD-1 Antagonist)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 01 Jul 2020

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At a glance

  • Drugs Eftilagimod alpha (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Non-small cell lung cancer; Oropharyngeal cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms TACTI-002
  • Sponsors Immutep Limited
  • Most Recent Events

    • 30 Jun 2020 According to an Immutep Limited media release, in total 81 patients out of up to 109 (74%) are already enrolled in the trial at 12 clinical sites across Australia, Europe, the UK and US. RCurrent recruitment numbers for each Part is Part A (Stage1-17/17, Stage2-19/19), Part B (Stage1-21/23 , Stage2 -/13), Part C (Stage1-18/18, Stage2-6/19).
    • 30 Jun 2020 According to an Immutep Limited media release, it has enrolled and safely dosed the last patient for stage 2 of Part A (1st line NSCLC) of this study, completing recruitment for Part A. More mature data expected in H2 CY20.
    • 29 Jun 2020 Planned End Date changed from 1 Jun 2021 to 1 Dec 2021.
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