Trials / Active Not Recruiting
Active Not RecruitingNCT06253195
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- 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 Chinese Patients With Advanced or Metastatic HR+/HER2- Breast Cancer and Other Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGB-43395 | Administered orally. |
| DRUG | Fulvestrant | Administered via intramuscular injection. |
| DRUG | Letrozole | Administered orally. |
Timeline
- Start date
- 2024-04-01
- Primary completion
- 2026-02-28
- Completion
- 2026-10-26
- First posted
- 2024-02-12
- Last updated
- 2025-06-05
Locations
7 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06253195. Inclusion in this directory is not an endorsement.