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PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer

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Trial Profile

PIKture-01: First-in-Human Study of the PI3KαH1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Fulvestrant (Primary) ; OKI-219 (Primary) ; Trastuzumab (Primary)
  • Indications Advanced breast cancer; Colorectal cancer; HER2 negative breast cancer; HER2 positive breast cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus Adverse reactions; First in man
  • Acronyms PIKture-01
  • Sponsors OnKure Therapeutics

Most Recent Events

  • 06 May 2025 According to an OnKure Therapeutics media release, the company has completed dose escalating and closed enrollment in Part A and is actively enrolling patients in Part B of the study which is near the end of dose escalation portion. This study is on track to report additional data in 2H 2025, including mature single agent and initial Fulvestrant combination data.
  • 10 Dec 2024 According to an OnKure Therapeutics media release, across all three levels, a total of 17 patients have been dosed till Data cutoff date 28 Oct 2024.
  • 10 Dec 2024 According to an OnKure Therapeutics media release, data from this trial is scheduled to be presented during poster sessions at the 2024 San Antonio Breast Cancer Symposium (SABCS) on December 12, 2024.

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