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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05494762
Registration number
NCT05494762
Ethics application status
Date submitted
8/08/2022
Date registered
10/08/2022
Date last updated
1/05/2025
Titles & IDs
Public title
Safety, Pharmacokinetics, and Antitumor Activity of BGB-B167 Alone and in Combination With Tislelizumab (BGB-A317) in Participants With Advanced Solid Tumors
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Scientific title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B167, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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BGB-A317-B167-101
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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:
Solid Tumor
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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-B167
Treatment: Drugs - Tislelizumab
Experimental: Phase 1a: Dose Escalation - Part A: Increasing dose levels of BGB-B167 monotherapy; Part B: Increasing dose levels of BGB-B167 in combination with tislelizumab (BGB-A317)
Experimental: Phase 1b: Dose Expansion - BGB-B167 alone or in combination with tislelizumab (BGB-A317)
Treatment: Drugs: BGB-B167
Intravenous administration
Treatment: Drugs: Tislelizumab
Intravenous administration
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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 1a: Number of Participants Experiencing Adverse Events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to approximately 3 years
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Primary outcome [2]
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Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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Up to approximately 3 years
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Primary outcome [3]
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Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
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Assessment method [3]
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0
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Timepoint [3]
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Up to approximately 3 years
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Primary outcome [4]
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Phase 1a: Maximum tolerated dose (MTD)
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Assessment method [4]
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MTD is defined as the highest tolerated dose with the target toxicity rate of 30%
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Timepoint [4]
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Up to approximately 3 years
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Primary outcome [5]
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Phase 1a: Recommended Phase 2 doses (RP2Ds)
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Assessment method [5]
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RP2Ds of BGB-B167 alone or in combination with tislelizumab will be determined based on a biologically effective dose
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Timepoint [5]
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Up to 90 days after the last dose of study drug(s); up to approximately 3 years
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Primary outcome [6]
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Phase 1b: Objective Response Rate (ORR)
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Assessment method [6]
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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
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Timepoint [6]
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Up to approximately 3 years
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Secondary outcome [1]
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Phase 1a: ORR
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Assessment method [1]
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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
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Phase 1a and 1b: Duration of Response (DOR)
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Assessment method [2]
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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
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Phase 1a and 1b: Disease Control Rate (DCR)
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Assessment method [3]
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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
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Phase 1a and 1b: Clinical Benefit Rate (CBR)
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Assessment method [4]
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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
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Phase 1b: Progression-free Survival (PFS)
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Assessment method [5]
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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
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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Phase 1a and 1b: Serum Concentration of Tislelizumab
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Assessment method [6]
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Timepoint [6]
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Up to approximately 3 years
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Secondary outcome [7]
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Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167
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Assessment method [7]
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Timepoint [7]
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Up to approximately 3 years
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Secondary outcome [8]
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Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167
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Assessment method [8]
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Timepoint [8]
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Up to approximately 3 years
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Secondary outcome [9]
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Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167
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Assessment method [9]
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Timepoint [9]
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Up to approximately 3 years
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Secondary outcome [10]
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Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167
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Assessment method [10]
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Timepoint [10]
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Up to approximately 3 years
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Secondary outcome [11]
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Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
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Assessment method [11]
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Timepoint [11]
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Up to approximately 3 years
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Secondary outcome [12]
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Phase 1a and 1b: Total body clearance (CL) of BGB-B167
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Assessment method [12]
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Timepoint [12]
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Up to approximately 3 years
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Secondary outcome [13]
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Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167
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Assessment method [13]
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Timepoint [13]
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Up to approximately 3 years
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Secondary outcome [14]
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Phase 1b: Number of Participants with AEs or SAEs
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Assessment method [14]
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Timepoint [14]
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Up to approximately 3 years
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Secondary outcome [15]
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Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)
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Assessment method [15]
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Timepoint [15]
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Up to approximately 3 years
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Eligibility
Key inclusion criteria
* Age 18 or older
* Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors previously treated with standard systemic therapy or for whom treatment is not available, not tolerated, or refused, or not expected to provide significant clinical benefit or be tolerated in the medical judgement of the investigator
* Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
* Adequate organ function as indicated by laboratory values during screening or = 7 days before the first dose of study drug(s)
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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
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Active autoimmune diseases or history of autoimmune diseases that may relapse
* Any malignancy = 3 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent
* History of severe hypersensitivity reactions to other monoclonal antibody products or their excipients
* Women who are pregnant or are breastfeeding
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
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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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
25/08/2022
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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
24/02/2025
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Icon Cancer Centre Kurralta Park - Kurralta Park
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Recruitment hospital [3]
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Monash Health - Clayton
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Recruitment hospital [4]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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5037 - Kurralta Park
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Connecticut
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Country [3]
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United States of America
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State/province [3]
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Tennessee
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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
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.
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Trial website
https://clinicaltrials.gov/study/NCT05494762
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
See plan description
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Available to whom?
See plan description
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://beigene.com/science/clinical-trials/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05494762
Download to PDF