RECRUITING

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-12-01
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06120283

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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. For combination with elacestrant, participants must have received at least 1 prior line of treatment for advanced/metastatic disease including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
  3. * Phase 1b: Selected tumor cohorts will include HR+/HER2- breast cancer and additional tumor types.
  4. * 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.
  5. * Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  6. * Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.
  7. * Adequate organ function without symptomatic visceral disease.
  1. * Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted and required in local regions where it is approved and available).
  2. * Known leptomeningeal disease or uncontrolled, untreated brain metastases.
  3. * 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).
  4. * Uncontrolled diabetes.
  5. * Infection requiring systemic antibacterial, antifungal, or antiviral therapy ≤ 28 days before the first dose of study drug(s), or symptomatic COVID-19 infection.
  6. * 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.
  7. * Participants with active hepatitis C infection.
  8. * Prior allogeneic stem cell transplantation, or organ transplantation.

Contacts and Locations

Study Contact

Study Director
CONTACT
1.877.828.5568
clinicaltrials@beigene.com

Principal Investigator

Study Director
STUDY_DIRECTOR
BeiGene

Study Locations (Sites)

Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado, 80218-1238
United States
Florida Cancer Specialists and Research Institute
Lake Mary, Florida, 32746-2115
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201-2013
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110-1010
United States
Duke Cancer Center
Durham, North Carolina, 27710-2000
United States
James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210-1240
United States
Scri Oncology Partners
Nashville, Tennessee, 37203-1503
United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Next Dallas
Irving, Texas, 75039-2743
United States
Next Oncology
San Antonio, Texas, 78229-6028
United States

Collaborators and Investigators

Sponsor: BeiGene

  • Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-01
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-12-01
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • breast cancer
  • advanced solid tumor
  • advanced breast cancer
  • hormone receptor positive breast cancer
  • HER2-negative breast cancer
  • Hormone Receptor Positive HER-2 Negative Breast Cancer
  • BGB-43395
  • non-small cell lung cancer

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Advanced Breast Cancer
  • Metastatic Breast Cancer
  • Hormone-receptor-positive Breast Cancer
  • Hormone Receptor Positive Breast Carcinoma
  • Hormone Receptor Positive Malignant Neoplasm of Breast
  • HER2-negative Breast Cancer
  • Hormone Receptor Positive HER-2 Negative Breast Cancer
  • Non-small Cell Lung Cancer