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: 24 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 BeOne Medicines

17 Jun 2025 Planned number of patients changed from 79 to 300.
17 Jun 2025 Planned End Date changed from 1 May 2026 to 1 Jun 2028.
17 Jun 2025 Planned primary completion date changed from 1 May 2026 to 1 Jun 2028.

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