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First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Trial Profile

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 04 Jun 2025

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At a glance

  • Drugs Fulvestrant (Primary) ; STX-478 (Primary)
  • Indications Advanced breast cancer; Endometrial cancer; Gastrointestinal cancer; Gynaecological cancer; Head and neck cancer; HER2 negative breast cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
  • Sponsors Scorpion Therapeutics

Most Recent Events

  • 30 May 2025 Planned number of patients changed from 400 to 720.
  • 10 Dec 2024 Results published in the Scorpion Therapeutics media release
  • 10 Dec 2024 According to a Scorpion Therapeutics media release, company presented updated analyses from its Phase 1/2 study of STX-478 in advanced solid tumor patients in a poster spotlight presentation at the San Antonio Breast Cancer Symposium 2024

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