This study aims to evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors. Key details of the study include: * The study is expected to last about 36 months. * Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Administered intravenously
Administered intravenously
Administered in accordance with relevant local guidelines and/or prescribing information.
Phase 1a: Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the American Society for Transplantation and Cellular Therapy \[ASTCT\] consensus grading system for cytokine release syndrome \[CRS\]), and including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
Time frame: Up to 2 Years
Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered.
Time frame: Up to 2 Years
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab
The RDFEs of BGB-A3055, alone or in combination with tislelizumab will be determined based on biological effectiveness taking preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration.
Time frame: Up to 2 Years
Phase 1b (Dose Expansion): Objective Response Rate (ORR)
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Time frame: Up to 2 Years
Phase 1a: ORR
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Advent Health Cancer Institute
Orlando, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Next Dallas
Irving, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Chris Obrien Lifehouse
Camperdown, New South Wales, Australia
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
...and 16 more locations
Time frame: Up to 2 Years
Time to Response (TTR)
Defined as the time from the date of the first administration of study drug(s) to the first determination of an objective response.as determined from tumor assessments by the investigators per RECIST v1.1.
Time frame: Up to 2 Years
Duration of Response (DOR)
Defined as the time from the first determination of an objective response to the time of first documentation of radiographic progression, as determined from tumor assessments by the investigators per RECIST v1.1, or death from any cause, whichever comes first.
Time frame: Up to 2 Years
Disease Control Rate (DCR)
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease as determined from tumor assessments by the investigators per RECIST v1.1.
Time frame: Up to 2 Years
Clinical Benefit Rate (CBR)
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) as determined from tumor assessments by the investigators per RECIST v1.1.
Time frame: Up to 2 Years
Number of participants with anti-drug antibodies (ADAs) against BGB-A3055
Time frame: Up to 2 Years
Serum concentration of BGB-A3055 at specified time points
Time frame: Up to 2 Years
Phase 1b: Progression-Free Survival (PFS)
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as determined from tumor assessments by investigators per RECIST v1.1.
Time frame: Up to 2 Years
Phase 1b: Number of participants with adverse events (AEs)
Number of participants with TEAEs and SAEs graded according to the NCI-CTCAE version 5.0 and the ASTCT consensus grading system for CRS, and including findings from laboratory assessments, ECGs, and physical examinations.
Time frame: Up to 2 Years
Phase 1b: Association of CCR8 expression with clinical efficacy
Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.
Time frame: Up to 2 Years
Phase 1b: Association of PD-L1 expression with clinical efficacy
Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.
Time frame: Up to 2 Years