Trials / Recruiting
RecruitingNCT06120283
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 399 (estimated)
- Sponsor
- BeOne Medicines · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
- Advanced Solid Tumor
- Advanced Breast Cancer
- Metastatic Breast Cancer
- Hormone-receptor-positive Breast Cancer
- Hormone Receptor Positive Breast Carcinoma
- Hormone Receptor Positive Malignant Neoplasm of Breast
- HER2-negative Breast Cancer
- Hormone Receptor Positive HER-2 Negative Breast Cancer
- Non-small Cell Lung Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGB-43395 | Planned doses administered orally. |
| DRUG | Fulvestrant | Standard dose administered via intramuscular injection. |
| DRUG | Letrozole | Standard dose administered orally as a tablet. |
| DRUG | Elacestrant | Standard dose administered orally as a tablet. |
| DRUG | Anti-Diarrheal Agent | Administered orally as a tablet. |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2028-11-01
- Completion
- 2028-11-01
- First posted
- 2023-11-07
- Last updated
- 2026-04-15
Locations
63 sites across 11 countries: United States, Australia, Brazil, China, France, Japan, Malaysia, Moldova, New Zealand, South Korea, Thailand
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06120283. Inclusion in this directory is not an endorsement.