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An Open-Label Phase 2 Study of Maintenance Therapy With OST31-164 After Resection of Recurrent Osteosarcoma

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Trial Profile

An Open-Label Phase 2 Study of Maintenance Therapy With OST31-164 After Resection of Recurrent Osteosarcoma

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 11 Jun 2025

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At a glance

  • Drugs ADXS 31164 (Primary)
  • Indications Osteosarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms OST-164-01
  • Sponsors OS Therapies

Most Recent Events

  • 06 Jun 2025 According to an OS Therapies media release, Company intends to begin a rolling BLA submission in the third quarter of 2025. The grant of the RMAT designation in the third quarter of 2025 complements parallel efforts in other major markets, including Europe and the United Kingdom, where the company plans to seek EMA PRIME Designation and Conditional Market Access (CMA) applications.
  • 06 Jun 2025 According to an OS Therapies media release, The Company is awaiting feedback by mid-June 2025 from a Type D meeting with FDA regarding the statistical analysis plan to be used in an End of Phase 2 meeting for OST-HER2 in the prevention of metastases in recurrent, fully-resected, lung metastatic pediatric osteosarcoma.
  • 16 May 2025 According to an OS Therapies media release, company anticipate BLA submission in Q3 2025 for OST-HER2 in the prevention of recurrent, fully resected, lung metastatic pediatric osteosarcoma.

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