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

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 18 Jun 2026

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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 BeOne Medicines

10 Jun 2026 Status changed from active, no longer recruiting to completed.
27 May 2025 According to BeOne Medicines media release, BeiGene is now called BeOne Medicines
20 May 2025 Status changed from recruiting to active, no longer recruiting.

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