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A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors

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Trial Profile

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 20 May 2025

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At a glance

  • Drugs TOS-358 (Primary)
  • Indications Cervical cancer; Colorectal cancer; Endometrial cancer; Gastric cancer; Head and neck cancer; HER2 negative breast cancer; Non-small cell lung cancer; Ovarian cancer; Solid tumours; Squamous cell cancer; Urogenital cancer
  • Focus Adverse reactions
  • Sponsors Totus Medicines

Most Recent Events

  • 10 Jan 2025 According to a Totus Medicines media release, company announced Successful Completion of a Phase 1 Dose-Escalation Study and Initiation of an Expansion Trial in breast, endometrial, urothelial and head and neck cancers at 5 & 8 mg BID.
  • 19 Apr 2023 Trial design presented at the 114th Annual Meeting of the American Association for Cancer Research
  • 13 Apr 2023 According to a Totus Medicines media release, the first patient has been dosed in the study.

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