This is an open-label, multicenter, Phase 1a/1b clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-60366, a highly potent, selective EGFR-mutation targeted Chimeric Degradation Activation Compound (CDAC). BG-60366 is designed to degrade mutant EGFR, which is a common cause for Non-Small Cell Lung Cancer (NSCLC). This study will evaluate how well BG-60366 works in participants with advanced or metastatic EGFR-mutant NSCLC. The study will be conducted in 2 parts: 1) Phase 1a Dose Escalation and Safety Expansion, and 2) Phase 1b Dose Expansion.
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
33
Administered orally
University of Colorado
Denver, Colorado, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States
Ohio State University
Columbus, Ohio, 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 laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 18 months)
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Time frame: Approximately 1 month
Phase 1a: Recommended dose(s) for expansion (RDFE) of BG-60366
RDFE of BG-60366 will be determined based upon the MTD or MAD.
Time frame: Approximately 18 months
Phase 1b: Number of Participants with Adverse Events and Serious Adverse Events
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, and laboratory assessments as needed.
Time frame: From first dose of the study drug to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first (approximately 24 months)
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Approximately 24 months
Phase 1a: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed CR or PR assessed by the investigator using RECIST v1.1.
Time frame: Approximately 24 months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first determination of objective response that is confirmed by the subsequent assessment until the first documentation of disease progression or death, whichever comes first.
Time frame: Approximately 24 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 teh first determination of objective response that is confirmed by the subsequent assessment.
Time frame: Approximately 24 months
Phase 1b: Progression-Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug to the date of the first documentation of disease progression assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Time frame: Approximately 24 months
Phase 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with the best overall response of confirmed CR, PR, or stable disease assessed.
Time frame: Approximately 24 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Apparent terminal elimination half-life (t1/2) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Minimum observed plasma concentration (Cmin) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Apparent total clearance (CL/F) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Apparent volume of distribution (Vz/F) of BG-60366
Time frame: Twice in the first 3 months
Phase 1a and 1b: Accumulation Ratio (AR) of BG-60366
Time frame: Once in the first three months
Phase 1a and 1b: Plasma concentrations of BG-60366
Time frame: Approximately up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Cancer Research South Australia
Adelaide, South Australia, Australia
...and 19 more locations