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A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

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Trial Profile

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation

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

Latest Information Update: 04 Jul 2025

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At a glance

  • Drugs LOXO-783 (Primary) ; Abemaciclib; Anastrozole; Exemestane; Fulvestrant; Imlunestrant; Letrozole; Paclitaxel
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer; Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms PIKASSO-01
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 27 Jun 2025 Planned primary completion date changed from 1 May 2025 to 1 Dec 2025.
  • 18 Apr 2025 Planned End Date changed from 1 May 2025 to 1 Dec 2025.
  • 01 Nov 2024 According to an Eli Lilly and Company media release, data from this study will be presented at the San Antonio Breast Cancer Symposium (SABCS) taking place December 10-13 in San Antonio, TX

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