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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03379259




Registration number
NCT03379259
Ethics application status
Date submitted
11/12/2017
Date registered
20/12/2017

Titles & IDs
Public title
Study of BGB-A333 Alone and in Combination With Tislelizumab in Advanced Solid Tumors
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
Secondary ID [1] 0 0
2018-000265-37
Secondary ID [2] 0 0
BGB-900-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 and Phase 2 : Number of Participants With Adverse Events and Serious Adverse Events
Timepoint [1] 0 0
Up to 33.5 months
Primary outcome [2] 0 0
Phase 1 and Phase 2 : Number of Participants With Abnormalities During Physical Examinations - Ophthalmology Findings
Timepoint [2] 0 0
Up to 33.5 months
Primary outcome [3] 0 0
Phase 1 and Phase 2 : Number of Participants With Abnormal Electrocardiograms (ECG)
Timepoint [3] 0 0
Up to 33.5 months
Primary outcome [4] 0 0
Phase 1 and Phase 2 : Number of Participants With Abnormal Lab Assessment Results
Timepoint [4] 0 0
Up to 33.5 months
Primary outcome [5] 0 0
Phase 1 A: Recommended Phase 2 Dose (RP2D) for BGB-333
Timepoint [5] 0 0
Up to 28 months
Primary outcome [6] 0 0
Phase 2B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
Timepoint [6] 0 0
Up to 33.5 months
Secondary outcome [1] 0 0
Phase 1A and Phase 1B: Overall Response Rate (ORR) Determined by Investigators Based on RECIST Version 1.1
Timepoint [1] 0 0
Up to 33.5 months
Secondary outcome [2] 0 0
Phase 2B: Duration of Response (DOR) Determined by Investigators Based on RECIST Version 1.1
Timepoint [2] 0 0
Up to 33.5 months
Secondary outcome [3] 0 0
Phase 1 and Phase 2: Disease Control Rate (DCR) Determined by Investigators Based on RECIST Version 1.1
Timepoint [3] 0 0
Up to 33.5 months
Secondary outcome [4] 0 0
Phase 2B: Progression-free Survival (PFS) Determined by Investigators Based on RECIST Version 1.1
Timepoint [4] 0 0
Up to 33.5 months
Secondary outcome [5] 0 0
Phase 1: Maximum Plasma Concentration (Cmax) of BGB-A333
Timepoint [5] 0 0
Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Secondary outcome [6] 0 0
Phase 1: Time to Cmax (Tmax) of BGB-A333
Timepoint [6] 0 0
Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Secondary outcome [7] 0 0
Phase 1:Trough Serum Concentration (Ctrough) of BGB-A333
Timepoint [7] 0 0
Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Secondary outcome [8] 0 0
Phase 1: Time to Last Observed Concentration (Tlast) of BGB-A333
Timepoint [8] 0 0
Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Secondary outcome [9] 0 0
Phase 1: Area Under the Concentration-time Curve From 0 to 21 Days Post-dose (AUC 0-21day) of BGB-A333
Timepoint [9] 0 0
Cycle 1 Day 1 (Pre-dose, End of infusion, 6 hours), Day 2, Day 4, Day 8, Day 15 and Day 21
Secondary outcome [10] 0 0
Phase 1A and Phase 2: Number of Participants With Detectable Treatment-Emergent Anti-BGB-A333 Antibodies
Timepoint [10] 0 0
Up to 33.5 months

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

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/09/2020
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Nucleus Network - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Spain
State/province [2] 0 0
Barcelona
Country [3] 0 0
Spain
State/province [3] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03379259