OncRef

Clinical Trial: NCT06253195

BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:BeOne Medicines
Information Provided By:BeOne Medicines
Last Update Posted:2026-06-10

Study Overview

Brief Summary

This is an open-label, multicenter, phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, as monotherapy or in combination with fulvestrant, letrozole, or other combination partners in Chinese participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced or metastatic solid tumors.

Official Title

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

Conditions

Advanced Solid Tumor, Metastatic Solid Tumor, Hormone-receptor-positive Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, HER2-negative Breast Cancer

Intervention / Treatment

  • Drug: BGB-43395
  • Drug: Fulvestrant
  • Drug: Letrozole

Other Study ID Numbers

  • BGB-43395-102
  • CTR20240674

Start Date (Actual)

2024-04-01

Primary Completion Date (Actual)

2026-04-23

Study Completion Date (Actual)

2026-04-23

Enrollment (Actual)

33

Study Type

Interventional

Phase

Phase 1