Trial Title:
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
NCT ID:
NCT06120283
Condition:
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
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Letrozole
Fulvestrant
Conditions: Keywords:
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
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-43395
Description:
Planned doses administered orally.
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Intervention type:
Drug
Intervention name:
Fulvestrant
Description:
Standard dose administered via intramuscular injection.
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Intervention type:
Drug
Intervention name:
Letrozole
Description:
Standard dose administered orally as a tablet.
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute (Scri) At Health One
Address:
City:
Denver
Zip:
80219
Country:
United States
Status:
Recruiting
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
James Cancer Hospital and Solove Research Institute
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
The University of Texas Md Anderson Cancer Center
Address:
City:
Houston
Zip:
77030-4009
Country:
United States
Status:
Recruiting
Facility:
Name:
Next Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Blacktown Cancer and Haematology Centre
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Facility:
Name:
Macquarie University
Address:
City:
North Ryde
Zip:
2109
Country:
Australia
Status:
Recruiting
Facility:
Name:
Peter Maccallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Centre Eugene Marquis
Address:
City:
Rennes
Zip:
35043
Country:
France
Status:
Recruiting
Facility:
Name:
Institut de Cancerologie de Louest
Address:
City:
St Herblain
Zip:
44800
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Start date:
December 1, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120283
