The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
109
administered orally (PO)
Cedars Sinai Medical Center
Beverly Hills, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Phase 1a: Number of Participants and Severity Experiencing Adverse Events (AEs)
Time frame: Up to 30 days after the last dose of study drug
Phase 1a: Number of Participants and Severity Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 30 days after the last dose of study drug
Phase 1a: number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria
Time frame: From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days)
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245
The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33%.
Time frame: From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days)
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-3245
The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33%
Time frame: From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days)
Phase 1b: Objective Response Rate (ORR) as assessed by the investigator
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator
Time frame: Up to 24 months
Phase 1b: Further review of the ORR
ORR is defined as the percentage of participants with partial or complete response in up to 15 participants with tumors harboring BRAF fusion mutations
Time frame: Up to 24 months
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MD Anderson
Houston, Texas, United States
University of Virginia Comprehensive Cancer Centre
Charlottesville, Virginia, United States
Blacktown Hospital
Blacktown, New South Wales, Australia
The Kinghorn Cancer Centre, St Vincent Hospital Sydney
Sydney, New South Wales, Australia
One Clinical Research
Nedlands, Perth, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1a: Clinical Benefit Rate (CBR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1a: Best Overall Response (BOR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1a: Duration of Stable Disease (DSD)
Time frame: Up to 24 months
Phase 1a: Progression Free Survival (PFS)
Time frame: Up to 24 months
Phase 1a: Plasma Concentration of BGB-3245
Time frame: Within 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-3245
Time frame: Within 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Time Taken for Half the Initial Dose Administered To Be Eliminated From The Body (T1/2) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Area Under the Concentration-Time Curve of 0-infinity Days (AUC0-inf) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a:Area Under the Concentration-Time Curve of 0-Last hour (AUC0-last) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Drug Clearance (CL/F) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Apparent Volume of Distribution (Vz/F) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Steady State Area Under the Concentration-Time Curve of 0- Last hour (AUCLast, ss) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Steady State Maximum Observed Plasma Concentration (Cmax, ss) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Steady State Time to Maximum Plasma Concentration (Tmax, ss) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator
Time frame: Up to 36 months
Phase 1b: Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1b: Duration of Stable Disease (DSD) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1b: Clinical Benefit Rate (CBR) as Assessed by the Investigator
Time frame: Up to 24 months
Phase 1b: Overall Survival
Time frame: Up to 36 months
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 30 days after the last dose of study drug
Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 30 days after the last dose of study drug
Phase 1b: Plasma Concentration of BGB-3245
Time frame: 60 minutes predose up to 3 hours postdose
Phase 1b: Steady State Trough Observed Plasma Concentration (Ctrough, SS) of BGB-3245
Time frame: 60 minutes predose up to 72 hours postdose