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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

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
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
Secondary ID [1] 0 0
BGB-A317-B167-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of Participants Experiencing Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Phase 1a: Number of Participants Experiencing Serious Adverse Events (SAEs)
Timepoint [2] 0 0
Up to approximately 3 years
Primary outcome [3] 0 0
Phase 1a: Number of Participants Experiencing AEs Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria
Timepoint [3] 0 0
Up to approximately 3 years
Primary outcome [4] 0 0
Phase 1a: Maximum tolerated dose (MTD)
Timepoint [4] 0 0
Up to approximately 3 years
Primary outcome [5] 0 0
Phase 1a: Recommended Phase 2 doses (RP2Ds)
Timepoint [5] 0 0
Up to 90 days after the last dose of study drug(s); up to approximately 3 years
Primary outcome [6] 0 0
Phase 1b: Objective Response Rate (ORR)
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Phase 1a and 1b: Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Up to approximately 3 years
Secondary outcome [5] 0 0
Phase 1b: Progression-free Survival (PFS)
Timepoint [5] 0 0
Up to approximately 3 years
Secondary outcome [6] 0 0
Phase 1a and 1b: Serum Concentration of Tislelizumab
Timepoint [6] 0 0
Up to approximately 3 years
Secondary outcome [7] 0 0
Phase 1a and 1b: Maximum observed serum concentration (Cmax) of BGB-B167
Timepoint [7] 0 0
Up to approximately 3 years
Secondary outcome [8] 0 0
Phase 1a and 1b: Minimum observed serum concentration (Cmin) of BGB-B167
Timepoint [8] 0 0
Up to approximately 3 years
Secondary outcome [9] 0 0
Phase 1a and 1b: Time to reach maximum observed serum concentration (Tmax) of BGB-B167
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Phase 1a and 1b: Elimination half life (t1/2) of BGB-B167
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Phase 1a and 1b: Area under the concentration-time curve in 1 dosing interval (AUCtau) of BGB-B167
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
Phase 1a and 1b: Total body clearance (CL) of BGB-B167
Timepoint [12] 0 0
Up to approximately 3 years
Secondary outcome [13] 0 0
Phase 1a and 1b: Volume of distribution at steady state (Vss) of BGB-B167
Timepoint [13] 0 0
Up to approximately 3 years
Secondary outcome [14] 0 0
Phase 1b: Number of Participants with AEs or SAEs
Timepoint [14] 0 0
Up to approximately 3 years
Secondary outcome [15] 0 0
Phase 1a and 1b: Number of Participants with Antidrug Antibodies (ADAs)
Timepoint [15] 0 0
Up to approximately 3 years

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

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
Accrual to date
Final
55
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee

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?

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