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.
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
399
Planned doses administered orally.
Standard dose administered via intramuscular injection.
Standard dose administered orally as a tablet.
Standard dose administered orally as a tablet.
Administered orally as a tablet.
Sarah Cannon Research Institute (Scri) At Health One
Denver, Colorado, United States
RECRUITINGFlorida Cancer Specialists and Research Institute
Lake Mary, Florida, United States
COMPLETEDKarmanos Cancer Institute
Detroit, Michigan, United States
COMPLETEDWashington University School of Medicine
St Louis, Missouri, United States
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Time frame: Up to approximately 60 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached.
Time frame: Up to approximately 60 months
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395
RDFE of BGB-43395 alone or in combination with fulvestrant, letrozole, or elacestrant will be determined based upon the MTD or MAD.
Time frame: Up to approximately 60 months
Phase 1b: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to approximately 60 months
Phase 1a: ORR
ORR is defined as the percentage of participants who have confirmed CR or PR assessed by the investigator using RECIST v1.1.
Time frame: Up to approximately 60 months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Time frame: Up to approximately 60 months
Phase 1a and 1b: Time to Response (TTR)
TTR is defined as the time from the date of the first dose of study drugs to the date of the first determination of objective response by the investigator using RECIST v1.1.
Time frame: Up to approximately 60 months
Phase 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease assessed by the investigator using RECIST v1.1.
Time frame: Up to approximately 60 months
Phase 1b: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks.
Time frame: Up to approximately 60 months
Phase 1b: Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Time frame: Up to approximately 60 months
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
Time frame: Up to approximately 60 months
Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395 and its metabolite
Time frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395 and its metabolite
Time frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Phase 1a: Area under the concentration-time curve (AUC) of BGB-43395 and its metabolite
Time frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Phase 1a: Half-life (t1/2) of BGB-43395 and its metabolite
Time frame: From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
Phase 1b: Plasma concentrations of BGB-43395 and its metabolite
Time frame: From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days)
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Duke Cancer Center
Durham, North Carolina, United States
RECRUITINGJames Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
RECRUITINGScri Oncology Partners
Nashville, Tennessee, United States
RECRUITINGThe University of Texas Md Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNext Dallas
Irving, Texas, United States
RECRUITINGNext Oncology
San Antonio, Texas, United States
RECRUITING...and 53 more locations