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Purpose

This is a dose escalation and dose expansion study to compare how well BGB-43395, a cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with either fulvestrant or letrozole 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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Phase 1a (Dose Escalation) and 1b (Dose Expansion): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and others. - Phase 1a: Received prior therapy for their condition (if available) and should be refractory to or intolerant of standard-of-care therapies. In regions where approved and available, participants with HR+ breast cancer must have received at least 2 prior lines of treatment including endocrine therapy and a CDK4/6 inhibitor. - Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types. - Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6 inhibitors are approved and available must have received at least one line of therapy for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease. - 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.

Exclusion Criteria

  • Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available). - 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, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast). - 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. - History of hepatitis B or active hepatitis C infection. - Prior allogeneic stem cell transplantation, or organ transplantation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation 		Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant or letrozole to assess for safety and tolerability.
  • Drug: BGB-43395
    Planned doses administered orally.
  • Drug: Fulvestrant
    Standard dose administered via intramuscular injection.
  • Drug: Letrozole
    Standard dose administered orally as a tablet.
Experimental
Dose Expansion 		Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 (in combination with fulvestrant or letrozole) from Phase 1a will be evaluated in HR+ breast cancer and selected tumor-specific cohorts.
  • Drug: BGB-43395
    Planned doses administered orally.
  • Drug: Fulvestrant
    Standard dose administered via intramuscular injection.
  • Drug: Letrozole
    Standard dose administered orally as a tablet.

Recruiting Locations

Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado 80218-1238

Florida Cancer Specialists and Research Institute
Lake Mary, Florida 32746-2115

Karmanos Cancer Institute
Detroit, Michigan 48201-2013

Washington University School of Medicine
Saint Louis, Missouri 63110-1010

Duke Cancer Center
Durham, North Carolina 27710-2000

James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210-1240

Scri Oncology Partners
Nashville, Tennessee 37203-1503

The University of Texas Md Anderson Cancer Center
Houston, Texas 77030-4009

Next Dallas
Irving, Texas 75039-2743

Next Oncology
San Antonio, Texas 78229-6028

More Details

NCT ID
NCT06120283
Status
Recruiting
Sponsor
BeiGene

Study Contact

Study Director
1.877.828.5568
clinicaltrials@beigene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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