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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: 23 Feb 2026

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At a glance

  • Drugs TOS-358 (Primary)
  • Indications Advanced breast cancer; 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; First in man
  • Sponsors Totus Medicines

Most Recent Events

  • 12 Feb 2026 According to a Totus Medicines media release, company announced that updated Phase 1 clinical data from its ongoing study of TOS-358, a next-generation covalent PI3Ka inhibitor, will be presented in an oral session at the European Society for Medical Oncology (ESMO) Targeted Anticancer Therapies (TAT) Congress, taking place in Paris in March 2026.
  • 06 Jan 2026 According to a Totus Medicines media release, Phase 1b interim clinical data readouts expected in H2 2026.
  • 22 Jul 2025 Planned End Date changed from 1 Dec 2025 to 1 Dec 2026.

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