OncoMatch/Clinical Trials/NCT06120283
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
Is NCT06120283 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including BGB-43395 and Fulvestrant for advanced solid tumor.
Treatment: BGB-43395 · Fulvestrant · Letrozole · Elacestrant — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Breast Carcinoma
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: CDK4 dependency
solid tumors associated with dependency on CDK4
Required: ESR1 hormone receptor positive
HR+ breast cancer
Required: HER2 (ERBB2) HER2-negative
HER2-negative
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy
must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor
Must have received: CDK4/6 inhibitor
must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor
Cannot have received: CDK4 inhibitor (selective)
Exception: prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available
Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available)
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Adequate organ function without symptomatic visceral disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Sarah Cannon Research Institute (Scri) At Health One · Denver, Colorado
- Florida Cancer Specialists and Research Institute · Lake Mary, Florida
- Karmanos Cancer Institute · Detroit, Michigan
- Washington University School of Medicine · St Louis, Missouri
- Duke Cancer Center · Durham, North Carolina
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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