The purpose of this study is to determine the maximum tolerated dose (MTD), recommended dose for expansion (RDFE), safety and tolerability of BGB-10188 as monotherapy in participants with relapsed/refractory (R/R) mature B-cell malignancies; in combination with zanubrutinib in participants with R/R follicular lymphoma (FL), R/R mantle cell lymphoma (MCL) or R/R diffuse large B-cell lymphoma (DLBCL); and in combination with tislelizumab in participants with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Saint Vincents Hospital Sydney
Darlinghurst, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
...and 14 more locations
Part A: The recommended dose for expansion (RDFE) of BGB-10188 monotherapy
Time frame: Up to 8 Weeks
Part B: RDFE of BGB-10188 in combination with zanubrutinib
Time frame: Up to 8 Weeks
Part D: RDFE of BGB-10188 in combination with tislelizumab
Time frame: Up to 8 Weeks
Part E: Overall response rate (ORR)
ORR is defined as the proportion of participants achieving a partial response (PR) or better
Time frame: Up to approximately 5 years and 6 months
Parts A, B, D, and E: Number of participants experiencing Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 5 years and 6 months
Parts A, B, D, and E: Number of participants experiencing Severe Adverse Events (SAEs)
Time frame: Up to approximately 5 years and 6 months
Parts A, B, D and E: Number of participants experiencing Adverse Events (AEs) Leading to Discontinuation
Time frame: Up to approximately 5 years and 6 months
Parts A, B, and D: Overall response rate (ORR)
ORR is defined as the proportion of participants achieving a partial response (PR) or better
Time frame: Up to approximately 5 years and 6 months
Parts B, D, and E: Duration of response (DOR)
DOR is defined as the time from the first response documentation to the date that progression is documented after treatment initiation or death, whichever occurs first
Time frame: Up to approximately 5 years and 6 months
Parts B, D, and E: Time to response (TTR)
TTR is defined as the time from treatment initiation to the first documentation of response
Time frame: Up to approximately 5 years and 6 months
Part E: Progression-free survival (PFS)
PFS is defined as the time from treatment initiation to the first documentation of progression or death due to any cause, whichever happens first
Time frame: Up to approximately 5 years and 6 months
Parts D and E: Disease control rate (DCR)
Time frame: Up to approximately 5 years and 6 months
Parts A, B, D, and E: Observed maximum plasma concentration during a sample interval (Cmax) of BGB-10188
Time frame: Predose up to 7 days postdose
Parts A, B, D, and E: Area under the plasma concentration-time curve (AUC) of BGB-10188
Time frame: Predose up to 7 days postdose
Part E: Clinical Benefit Rate (CBR)
CBR is defined as proportion of participants with best overall response, as defined by RECIST v1.1, of a CR, PR, or at least 24 weeks of stable disease
Time frame: Up to approximately 5 years and 6 months
Part E: CA-125 Response Rate
CA-125 response rate is defined as the proportion of participants achieving a CA-125 response according to the Gynecological Cancer Center Intergroup criteria; a response has occurred if there is at least a 50% reduction in CA-125 levels from baseline
Time frame: Up to approximately 5 years and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.