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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03379259
Registration number
NCT03379259
Ethics application status
Date submitted
11/12/2017
Date registered
20/12/2017
Date last updated
9/11/2021
Titles & IDs
Public title
Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
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Scientific title
Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-PD-L1 Monoclonal Antibody BGB-A333 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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Secondary ID [1]
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2018-000265-37
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Secondary ID [2]
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BGB-900-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-A333
Treatment: Drugs - BGB-A317
Experimental: Phase 1A: BGB-A333 monotherapy dose escalation -
Experimental: Phase 2A: BGB-A333 monotherapy dose expansion -
Experimental: Phase 1B: BGB-A333 and BGB-A317 dose confirmation -
Experimental: Phase 2B: BGB-A333 and BGB-A317 dose expansion -
Treatment: Drugs: BGB-A333
Anti-PD-L1 antibody
Treatment: Drugs: BGB-A317
Anti-PD-1 antibodies
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
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Assessment method [1]
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Adverse events were assessed per the National Cancer Institute Common Terminology Criteria for Adverse Events NCI-CTCAE Version 4.03 Serious Adverse Events (SAEs) were monitored from the date of informed consent. All adverse events (AEs) and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
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Timepoint [1]
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Up to 33.5 months
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Primary outcome [2]
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Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings
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Assessment method [2]
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Complete physical examination including an evaluation of 1) head, eyes, ears, nose, throat, 2) cardiovascular, 3) dermatological, 4) musculoskeletal, 5) respiratory, 6) gastrointestinal, and 7) neurological systems was required to be performed at Screening. At subsequent visits (or as clinically indicated), limited, symptom-directed physical examinations were performed. Clinically significant Ophthalmology abnormalities were collected from case report forms. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
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Timepoint [2]
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Up to 33.5 months
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Primary outcome [3]
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Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)
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Assessment method [3]
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Central ECG data was used and the abnormality was determined by the evaluator (Investigating physician). Multiple tests such as QT, HR, PR, RR were used by the evaluator to determine abnormality. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
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Timepoint [3]
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Up to 33.5 months
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Primary outcome [4]
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Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results
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Assessment method [4]
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Lab abnormality was based on ANRIND: if the measurement value > upper limit of normal (ULN), it was considered Abnormal. All AEs and SAEs, were reported until either 30 days after the last dose of study drug or until initiation of a new anticancer therapy, whichever occurred first.
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Timepoint [4]
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Up to 33.5 months
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Primary outcome [5]
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Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333
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Assessment method [5]
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RP2D for BGB-A333 alone and in combination with tislelizumab was the maximum tolerated dose (MTD) or less, which was determined by testing increasing doses up to 1800 mg.
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Timepoint [5]
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Up to 28 months
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Primary outcome [6]
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Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
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Assessment method [6]
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The ORR is defined as the percentage of participants who had confirmed Complete Response (CR) or Partial response (PR) assessed by investigator using RECIST version 1.1
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Timepoint [6]
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Up to 33.5 months
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Secondary outcome [1]
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Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
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Assessment method [1]
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ORR is defined as the percentage of participants who had confirmed CR or PR assessed by investigator using RECIST version 1.1.
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Timepoint [1]
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Up to 33.5 months
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Secondary outcome [2]
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Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1
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Assessment method [2]
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DOR was defined as the time from the first determination of an objective response per RECIST version 1.1, until the first documentation of progression or death, whichever occurs first. DOR was not evaluable in Phase 1A and Phase 1B.
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Timepoint [2]
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Up to 33.5 months
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Secondary outcome [3]
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Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1
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Assessment method [3]
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DCR is defined as the percentage of participants with best overall response of CR, PR and Stable Disease.
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Timepoint [3]
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Up to 33.5 months
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Secondary outcome [4]
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Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1
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Assessment method [4]
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PFS was defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of disease progression assessed by investigator using RECIST v1.1 or death, whichever occurs first
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Timepoint [4]
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Up to 33.5 months
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Secondary outcome [5]
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Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333
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Assessment method [5]
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PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B pharmacokinetic (PK) parameters were not estimated due to limited sampling.
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Timepoint [5]
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Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
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Secondary outcome [6]
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Phase 1: Time to Cmax (Tmax) of BGB-A333
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Assessment method [6]
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PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
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Timepoint [6]
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Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
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Secondary outcome [7]
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Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333
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Assessment method [7]
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PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
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Timepoint [7]
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Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
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Secondary outcome [8]
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Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333
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Assessment method [8]
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PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling. Actual observed time values for PK sampling, have an allowable time deviation (+/- 3 days) from the planned nominal time as pre-specified in the Visit Window section of the study protocol.
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Timepoint [8]
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Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
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Secondary outcome [9]
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Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333
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Assessment method [9]
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PK parameters were derived only for Phase 1A and Phase 1B. Phase 2B PK parameters were not estimated due to limited sampling.
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Timepoint [9]
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Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
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Secondary outcome [10]
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Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies
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Assessment method [10]
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Treatment-emergent anti drug antibodies (ADA) was the sum of both treatment-induced ADA and treatment-boosted ADA, synonymous with "ADA Incidence."
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Timepoint [10]
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Up to 33.5 months
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Eligibility
Key inclusion criteria
Key
1. Histologically or cytologically confirmed advanced or metastatic disease
(unresectable) that is resistant to standard therapy or for which treatment is not
available, not tolerated or refused
2. Has Eastern Cooperative Oncology Group (ECOG) Performance Status =1
3. Has adequate organ function
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Active brain or leptomeningeal metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse.
3. With severe chronic or active infections requiring systemic antibacterial, antifungal
or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is
permitted for participants with hepatocellular carcinoma)
4. Concurrent participation in another therapeutic clinical trial.
5. Received prior therapies targeting PD-1 or PD-L1.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/11/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/09/2020
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Sample size
Target
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Accrual to date
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Final
39
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Nucleus Network - Melbourne
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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Linear Clinical Research - Perth
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Grafton
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Country [2]
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Spain
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State/province [2]
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Barcelona
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Country [3]
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Spain
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State/province [3]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
BGB-A333 is a humanized IgG1-variant monoclonal antibody against programmed cell death
1-ligand 1 (PD-L1), the ligand of an immune check point- receptor, programmed cell death-1
(PD-1). BGB-A317 is a humanized, IgG4-variant monoclonal antibody against PD-1. This study
tested the safety and anti-tumor effect of BGB-A333 alone and in combination with BGB-A317 in
participants with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03379259
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03379259
Download to PDF