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A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

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Trial Profile

A Phase 1/2a, Open-Label, Dose Escalation and Expansion Study of the Safety and Tolerability of T3011 Administered Via Intratumoral Injection as a Single Agent and in Combination With Intravenous Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 22 Mar 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; T 3011 (Primary)
  • Indications Head and neck cancer; Malignant melanoma; Mesothelioma; Non-small cell lung cancer; Sarcoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Immvira Pharma

Most Recent Events

  • 15 Mar 2024 According to an Immvira Pharma media release, company announced that the U.S. Food and Drug Administration has granted Fast Track designation for MVR-T3011 IT (intratumoral injection) for the treatment of recurrent or metastatic head and neck squamous cell cancer with disease progression after platinum-based chemotherapy and at least one prior line of anti-PD1/PDL1 therapy. Supporting evidence for this request was derived from Phase I/II trials conducted in both the United States and China.
  • 28 Aug 2023 Planned End Date changed from 31 Aug 2030 to 31 Oct 2025.
  • 28 Aug 2023 Planned primary completion date changed from 31 Jul 2030 to 31 Oct 2023.

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