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A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Chinese Patients With Advanced or Metastatic HR+/HER2- Breast Cancer and Other Solid Tumors

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A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Chinese Patients With Advanced or Metastatic HR+/HER2- Breast Cancer and Other Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs BGB-43395 (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer; Solid tumours
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Sponsors BeiGene

    • Most Recent Events

    • 27 Feb 2025 According to a BeiGene media release, proof-of-concept data expected in the first half of 2025.
    • 16 Apr 2024 Status changed from not yet recruiting to recruiting.
    • 15 Feb 2024 New trial record

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