The purpose of this study is to evaluate the safety and tolerability of BGB-11417 monotherapy, define the maximum tolerated dose (MTD) or maximum administered dose and the recommended Phase 2 dose (RP2D) of BGB-11417 monotherapy for the selected B-cell malignancy dose finding cohorts, and evaluate the safety and tolerability of the ramp-up dosing schedule in the evaluated disease types.
This study will have 3 cohorts for determining a monotherapy MTD and ramp-up schedule: Cohort A, participants with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R NHL); Cohort B, participants with R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) with low tumor burden; Cohort C, participants with R/R CLL/SLL with high tumor burden.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Film-coated tablets administered orally as specified in the treatment arm.
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
MTD Of BGB-11417 As Recommended By The Bayesian Logistic Regression Model Or The MAD
Time frame: Approximately 3 years
RP2D Of BGB-11417
The RP2D will be decided by the sponsor and based on the safety monitoring committee recommendation considering totality of data.
Time frame: Approximately 3 years
Incidence And Severity Of Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events (AEs) Leading To Discontinuation, And Dose-Limiting Toxicities (DLTs)
All AEs, including DLT events, will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (or the Grading Scale for Hematologic Toxicity in CLL Studies as appropriate).
Time frame: Approximately 3 years
Incidence And Severity Of Tumor Lysis Syndrome-relevant Events
Time frame: Approximately 3 years
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Time To Maximum Observed Plasma Concentration (tmax) Of BGB-11417
Time frame: Up to 24 hours postdose
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Shenzhen Peoples Hospital
Shenzhen, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
...and 1 more locations
PK As Assessed By Terminal Half-life (t1/2) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Apparent Total Clearance Of Drug From Plasma After Oral Administration (CL/F) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Apparent Volume Of Distribution (Vz/F) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To Last Measurable Concentration At Steady State (AUClast,ss) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Trough Concentration At Steady State (Ctrough,ss) Of BGB-11417
Time frame: Up to 24 hours postdose
PK As Assessed By Time To Maximum Observed Plasma Concentration At Steady State (tmax,ss) Of BGB-11417
Time frame: Up to 24 hours postdose
Overall Response Rate (ORR) Of BGB-11417 Monotherapy
ORR will be assessed per disease-specific response assessment guidelines as determined by the investigator.
Time frame: Approximately 3 years