This study will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BGB-B167 monotherapy and in combination with tislelizumab (BGB-A317) in participants with select advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Intravenous administration
Intravenous administration
City of Hope National Medical Center
Duarte, California, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Blacktown Cancer and Haematology Centre
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to approximately 3 years
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Time frame: Up to approximately 3 years
Phase 1a: Maximum tolerated dose (MTD)
MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
Time frame: Up to approximately 3 years
Phase 1a: Recommended Phase 2 doses (RP2Ds)
RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
Time frame: Up to 90 days after the last dose of study drug(s); up to approximately 3 years
Phase 1b: Objective Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 3 years
Phase 1a: ORR
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined by investigators per RECIST v1.1
Time frame: Up to approximately 3 years
Phase 1a and 1b: Duration of Response (DOR)
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Blacktown, New South Wales, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
DOR is defined as the time from the first determination of a confirmed objective response until the first documentation of progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
Time frame: Up to approximately 3 years
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response (BOR) of confirmed CR, PR, or stable disease, as determined by investigators per RECIST v1.1
Time frame: Up to approximately 3 years
Phase 1a and 1b: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of patients with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks, as determined by investigators per RECIST v1.1
Time frame: Up to approximately 3 years
Phase 1b: Progression-free Survival (PFS)
PFS is defined as the time from the date of the first administration of study drug to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined by investigators per RECIST v1.1
Time frame: Up to approximately 3 years
Phase 1a and 1b: Serum Concentration of Tislelizumab
Time frame: Up to approximately 3 years
Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Total body clearance (CL) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167
Time frame: Up to approximately 3 years
Phase 1b: Number of Participants with AEs or SAEs
Time frame: Up to approximately 3 years
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)
Time frame: Up to approximately 3 years