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Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas

Trial Profile

Phase 1 Trial of the LSD1 Inhibitor Seclidemstat (SP 2577) With and Without Topotecan and Cyclophosphamide in Patients With Relapsed or Refractory Ewing Sarcoma and Select Sarcomas

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

Latest Information Update: 28 Feb 2024

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At a glance

  • Drugs Seclidemstat (Primary) ; Cyclophosphamide; Topotecan
  • Indications Ewing's sarcoma; Myxoid liposarcoma; Sarcoma; Soft tissue sarcoma
  • Focus Adverse reactions; Proof of concept
  • Sponsors Salarius Pharmaceuticals
  • Most Recent Events

    • 22 Feb 2024 According to a Salarius Pharmaceuticals media release, the company has completed FDA Type B End of Phase 2 (EOP2) meeting process for the Seclidemstat Ewing sarcoma development program and has amended the current clinical trial protocol to reflect guidance agreed to with FDA. There is currently one patient enrolled in the Ewing sarcoma clinical trial, who recently achieved a partial response defined by a 30% or greater reduction in their target lesions, and this patient is continuing treatment.
    • 22 Feb 2024 According to a Salarius Pharmaceuticals media release, the company is extending cash runway into the first half of 2025 by implementing additional cost saving which will support results generation from this trial. The company expects reviewing the updated clinical data later this year and to sharing those data with prospective strategic partners and other interested parties.
    • 22 Feb 2024 Results presented in the Salarius Pharmaceuticals media release.
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