Recruiting INTERVENTIONAL NCT06120283

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

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

Sponsor: BeOne Medicines

Conditions Advanced Breast Cancer Advanced Solid Tumor HER2-negative Breast Cancer Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive HER-2 Negative Breast Cancer Hormone Receptor Positive Malignant Neoplasm of Breast Hormone-receptor-positive Breast Cancer Metastatic Breast Cancer Non-small Cell Lung Cancer

Interventions Anti-Diarrheal Agent BGB-43395 Elacestrant Fulvestrant Letrozole

Updated 24 times since 2023 Last updated: Apr 10, 2026 Started: Dec 1, 2023 Primary completion: Nov 1, 2028 Completion: Nov 1, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Advanced Breast Cancer and Advanced Solid Tumor, this trial is actively recruiting participants. The trial is conducted by BeOne Medicines and has accumulated 24 data snapshots since 2023. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Status Flow

Change History

24 versions recorded

Apr 16, 2026 — Present [daily]

Recruiting

Phase: PHASE1 → None
Feb 2026 — Apr 2026 [monthly]

Recruiting PHASE1
Jan 2026 — Feb 2026 [monthly]

Recruiting PHASE1
Dec 2025 — Jan 2026 [monthly]

Recruiting PHASE1
Oct 2025 — Dec 2025 [monthly]

Recruiting PHASE1

▶ Show 19 earlier versions

Sep 2025 — Oct 2025 [monthly]

Recruiting PHASE1
Aug 2025 — Sep 2025 [monthly]

Recruiting PHASE1
Jul 2025 — Aug 2025 [monthly]

Recruiting PHASE1
Jun 2025 — Jul 2025 [monthly]

Recruiting PHASE1
May 2025 — Jun 2025 [monthly]

Recruiting PHASE1
Apr 2025 — May 2025 [monthly]

Recruiting PHASE1
Mar 2025 — Apr 2025 [monthly]

Recruiting PHASE1
Feb 2025 — Mar 2025 [monthly]

Recruiting PHASE1
Jan 2025 — Feb 2025 [monthly]

Recruiting PHASE1
Nov 2024 — Jan 2025 [monthly]

Recruiting PHASE1
Oct 2024 — Nov 2024 [monthly]

Recruiting PHASE1
Sep 2024 — Oct 2024 [monthly]

Recruiting PHASE1
Aug 2024 — Sep 2024 [monthly]

Recruiting PHASE1
Jul 2024 — Aug 2024 [monthly]

Recruiting PHASE1
May 2024 — Jul 2024 [monthly]

Recruiting PHASE1
Mar 2024 — May 2024 [monthly]

Recruiting PHASE1
Feb 2024 — Mar 2024 [monthly]

Recruiting PHASE1
Jan 2024 — Feb 2024 [monthly]

Recruiting PHASE1

Status: Not Yet Recruiting → Recruiting
Dec 2023 — Jan 2024 [monthly]

Not Yet Recruiting PHASE1

First recorded

Eligibility Summary

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Contact Information

Sponsor contact:

BeOne Medicines

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adelaide, Australia , Auckland, New Zealand , Barretos, Brazil , Beijing, China , Blacktown, Australia , Bordeaux, France , Bowral, Australia , Brasília, Brazil , Caen, France , Chisinau, Moldova and 53 more locations