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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 Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

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Trial Profile

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 Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 07 Jun 2025

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At a glance

  • Drugs BGB-43395 (Primary) ; Fulvestrant (Primary) ; Letrozole (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; 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.
  • 08 May 2024 According to a BeiGene media release, initiated fourth dose level of monotherapy, which is in the efficacious dose range with no dose limiting toxicities observed; and initiated dosing of combination with fulvestrant just over four months from first monotherapy dose.
  • 26 Feb 2024 According to a BeiGene media release, fully enrolled the first two cohorts in Phase 1 clinical trials for NME BGB-43395 (CDK4 inhibitor)

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