BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Public ClinicalTrials.gov record NCT06120283. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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 Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06120283
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 433 participants
Conditions and interventions
Conditions
Interventions
- BGB-43395 Drug
- Fulvestrant Drug
- Letrozole Drug
- Elacestrant Drug
- Anti-Diarrheal Agent Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2023
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
- Last update posted
- Aug 27, 2026
2023 – 2029
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sarah Cannon Research Institute (Scri) At Health One | Denver | Colorado | 80218-1238 | Recruiting |
| Florida Cancer Specialists and Research Institute | Lake Mary | Florida | 32746-2115 | Completed |
| Karmanos Cancer Institute | Detroit | Michigan | 48201-2013 | Completed |
| Washington University School of Medicine | St Louis | Missouri | 63110-1010 | Recruiting |
| Duke Cancer Center | Durham | North Carolina | 27710-2000 | Recruiting |
| James Cancer Hospital and Solove Research Institute | Columbus | Ohio | 43210-1240 | Recruiting |
| Scri Oncology Partners | Nashville | Tennessee | 37203-1503 | Recruiting |
| The University of Texas Md Anderson Cancer Center | Houston | Texas | 77030-4009 | Recruiting |
| Next Dallas | Irving | Texas | 75039-2743 | Recruiting |
| Next Oncology | San Antonio | Texas | 78229-6028 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06120283, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06120283 live on ClinicalTrials.gov.