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A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

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Trial Profile

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 18 May 2024

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At a glance

  • Drugs Cisplatin/vinblastine (Primary) ; Eribulin; Pazopanib; Trabectedin
  • Indications Leiomyosarcoma; Liposarcoma; Malignant fibrous histiocytoma; Soft tissue sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms INVINCIBLE-3
  • Sponsors Intensity Therapeutics
  • Most Recent Events

    • 09 May 2024 According to an Intensity Therapeutics media release, company continues to qualify new sarcoma specialty hospitals in the US and internationally, and top enrolling centers from Intensity Therapeutics' previous metastatic study have expressed interest in participating in the INVINCIBLE-3 trial. Sites are being recruited and company continues to work towards initiating the study in mid-2024.
    • 08 Feb 2024 Status changed from planning to not yet recruiting.
    • 03 Jan 2024 According to an Intensity Therapeutics media release, the Company requested and was granted a meeting that was held with the FDA to review the INT230-6 chemical manufacturing and controls for INT230-6. The CMC discussion focused on the tasks necessary to initiate the phase 3 study and future product registration as part of a potential New Drug Application (NDA). the Company and FDA agreed upon a plan for the CMC set of activities for the drug product (INT230-6) necessary for the NDA.
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