The purpose of this study is to assess the safety and tolerability of BGB-A445 alone and in combination with tislelizumab in participants with advanced solid tumors; and to determine the maximum tolerated dose(s) (MTD) or maximum administered dose(s) (MAD) and recommended Phase 2 doses (RP2D) of BGB-A445 alone and in combination with tislelizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
204
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Valkyrie Clinical Trials
Los Angeles, California, United States
California Cancer Associates for Research & Excellence (cCARE)
San Diego, California, United States
UPMC Hillman Cancer Center (Univ Of Pittsburgh)
Pittsburgh, Pennsylvania, United States
Blacktown Cancer And Haematology Centre
Blacktown, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Phase 1a: Number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria
Time frame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Phase 1a: Maximum Tolerated Dose (MTD) of BGB-A445
The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1b: RP2D of BGB-A445 when Administered Alone
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1b: Overall Response Rate (ORR) as Assessed by the Investigator
ORR is defined as the proportion of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1a: Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1a: Disease-Control Rate (DCR) as Assessed by the Investigator
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1a: Serum Concentration of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Serum Concentration of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Maximum Observed Plasma Concentration (Cmax) of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Minimum Observed Plasma Concentration (Cmin) of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Time to Maximum Plasma Concentration (Tmax) of tislelizumab
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1a: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445
Time frame: 60 minutes predose up to 21 days postdose
Phase 1a: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1a: Immunogenic Responses to tislelizumab as assessed through the detection of antidrug antibodies
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator
Determined from investigator derived tumor assessments as per RECIST 1.1
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1b: Duration of Response (DOR) as Assessed by the Investigator
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
Phase 1b: Number of Participants Experiencing Adverse Events (AEs)
Time frame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Up to 90 days after the last dose of study drug(s) regardless of whether the participant starts a subsequent anticancer therapy
Phase 1b: Serum Concentration of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Maximum Observed Plasma Concentration (Cmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Minimum Observed Plasma Concentration (Cmin) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Time to Maximum Plasma Concentration (Tmax) of BGB-A445
Time frame: 60 minutes predose up to 72 hours postdose
Phase 1b: Area Under the Concentration-Time Curve of 0-21 Days (AUC0-21d) of BGB-A445
Time frame: 60 minutes predose up to 21 days postdose
Phase 1b: Immunogenic Responses to BGB-A445 as assessed through the detection of antidrug antibodies
Time frame: Up to 30 days after the last dose of study drug(s) or before the initiation of a new anticancer treatment, whichever occurs first
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Princess Alexandra Hospital
Brisbane, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Nucleus Network
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
...and 20 more locations