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New treatment option for Advanced Solid Tumor
Official title BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06120283
What this study is testing
What is BGB-43395?
BGB-43395 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated...
- Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have...
- Phase 1b: Participants with HR+/HER2- breast cancer.
- Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and...
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
You likely can't join if
- Known leptomeningeal disease or uncontrolled, untreated brain metastases.
- Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally...
- Uncontrolled diabetes.
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic...
- Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at...
- Participants with active hepatitis C infection.
See the full eligibility criteria
- Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer...
- Phase 1a Safety Expansion: For combination with fulvestrant in regions where approved and available, participants with HR+ breast cancer must have received at least 1 prior line of treatment including endocrine therapy...
- Phase 1b: Participants with HR+/HER2- breast cancer.
- Phase 1b: For combination with fulvestrant, participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received 1-2 lines of therapy for...
- Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
- Adequate organ function without symptomatic visceral disease.
- Known leptomeningeal disease or uncontrolled, untreated brain metastases.
- Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg...
- Uncontrolled diabetes.
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
- Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers with HBV DNA ≥ 500 IU/mL (or ≥ 2500 copies/mL) at screening.
- Participants with active hepatitis C infection.
- Prior allogeneic stem cell transplantation, or organ transplantation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Lake Mary, Florida, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Irving, Texas, United States
- San Antonio, Texas, United States
- Blacktown, New South Wales, Australia
- Bowral, New South Wales, Australia
- Concord, New South Wales, Australia
- North Ryde, New South Wales, Australia
- Douglas, Queensland, Australia
- Adelaide, South Australia, Australia
- Heidelberg, Victoria, Australia
- Melbourne, Victoria, Australia
- Barretos, Brazil
- Brasília, Brazil
+ 41 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Lake Mary, Florida, United States; Detroit, Michigan, United States; St Louis, Missouri, United States; Durham, North Carolina, United States; Columbus, Ohio, United States and 55 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.