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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: 15 Jan 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

    • 09 Jan 2020 According to an Immutep Limited media release, recruitment of 18 HNSCC patients completed for stage 1 of Part C.Part C has been expanded to include an additional 19 HNSCC patients, creating stage 2 of Part C.Recruitment is ongoing for Part B (second line NSCLC) with 10 out of 23 patients now participating, and for stage 2 of Part A (first line NSCLC), where 4 out of 19 patients are now participating.
    • 08 Nov 2019 According to an Immutep Limited media release, The Company expects to report more mature data from TACTI-002 in Q1 of 2020.
    • 08 Nov 2019 Immutep has now commenced the recruitment of an additional 19 patients with first line NSCLC, known as stage 2 of Part A. This follows the Data Monitoring Committee's decision based on its review of preliminary safety and efficacy data. Recruitment is ongoing for Part B (second line NSCLC) with 8 out of 23 patients recruited and Part C (second line HNSCC) with 14 out of 18 patients recruited, as reported in an Immutep Limited media release
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