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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06756932




Registration number
NCT06756932
Ethics application status
Date submitted
24/12/2024
Date registered
3/01/2025
Date last updated
11/02/2025

Titles & IDs
Public title
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
Scientific title
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-21447 (a Bcl-2 Inhibitor) Combinations for Patients With HR+/HER2- Metastatic Breast Cancer
Secondary ID [1] 0 0
CTR20250114
Secondary ID [2] 0 0
BGB-21447-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone-receptor-positive Breast Cancer 0 0
HER2-negative Breast Cancer 0 0
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-21447
Treatment: Drugs - Fulvestrant
Treatment: Drugs - BGB-43395

Experimental: Part A: BGB-21447 + Fulvestrant - Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant.

Experimental: Part B: BGB-21447 + BGB-43395 + Fulvestrant - Sequential cohorts of increasing dose levels of BGB-21447 will be evaluated in combination with fulvestrant and BGB-43395.


Treatment: Drugs: BGB-21447
Administered orally.

Treatment: Drugs: Fulvestrant
Administered via intramuscular injection.

Treatment: Drugs: BGB-43395
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 6 months
Primary outcome [2] 0 0
Recommended Dose for Expansion (RDFE) of BGB-21447 in combination with fulvestrant and in combination with fulvestrant and BGB-43395
Timepoint [2] 0 0
Approximately 6 to 9 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Approximately 12 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Approximately 12 months
Secondary outcome [3] 0 0
Time to Response (TTR)
Timepoint [3] 0 0
Approximately 12 months
Secondary outcome [4] 0 0
Maximum observed plasma concentration (Cmax) of BGB-21447, BGB-43395, and BGB-43395 metabolite
Timepoint [4] 0 0
Up to approximately 2 months
Secondary outcome [5] 0 0
Time to reach maximum observed plasma concentration (Tmax) of BGB-21447, BGB-43395, and BGB-43395 metabolite
Timepoint [5] 0 0
Up to approximately 2 months
Secondary outcome [6] 0 0
Area under the concentration-time curve (AUC) of BGB-21447, BGB-43395, and BGB-43395 metabolite
Timepoint [6] 0 0
Up to approximately 2 months
Secondary outcome [7] 0 0
Apparent terminal elimination half-life (t1/2) of BGB-21447, BGB-43395, and BGB-43395 metabolite
Timepoint [7] 0 0
Up to approximately 2 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed HR+/HER2- metastatic breast cancer. Participants must have received at least 2 prior lines of treatment for metastatic disease, including prior endocrine therapy and CDK4/6 inhibitor in either the adjuvant or advanced/metastatic setting.
* Female participants with metastatic breast cancer will be required (either continue ongoing or initiate as soon as feasible) to have ovarian function suppression using GnRH agonists (such as goserelin) or be postmenopausal.
* Male participants will be required to use gonadotropin-releasing hormone (GnRH) agonists when being treated with aromatase inhibitors and can be treated with GnRH agonists when being treated with fulvestrant at the discretion of the investigator.
* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of = 1.
* Adequate organ function.
* Female participants of childbearing potential and nonsterile male participants with female partners of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for 90 days after the last dose of BGB-21447, 3 months after the last dose of BGB-43395, and 2 years after the last dose of fulvestrant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior Bcl-2 inhibitor exposure.
* 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, treated papillary thyroid carcinoma, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
* Uncontrolled diabetes.
* History of hepatitis B or active Hepatitis C infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Western Health - Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
3021 - Saint Albans

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast cancer.
Trial website
https://clinicaltrials.gov/study/NCT06756932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06756932