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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06634589




Registration number
NCT06634589
Ethics application status
Date submitted
8/10/2024
Date registered
10/10/2024

Titles & IDs
Public title
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
Scientific title
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
Secondary ID [1] 0 0
2024-516234-35-00
Secondary ID [2] 0 0
BGB-16673-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Malignancy 0 0
Relapsed Cancer 0 0
Refractory Cancer 0 0
B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-16673
Treatment: Drugs - sonrotoclax
Treatment: Drugs - Zanubrutinib

Experimental: Substudy 1 Part 1a: Dose Escalation - Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated.

Experimental: Substudy 1 Part 1b: Safety Expansion - Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell histologies.

Experimental: Substudy 2 Part 1a: Dose Escalation - Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated.

Experimental: Substudy 2 Part 1b: Safety Expansion - Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell histologies.


Treatment: Drugs: BGB-16673
Administered orally

Treatment: Drugs: sonrotoclax
Administered orally

Treatment: Drugs: Zanubrutinib
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Substudy 1 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
Timepoint [1] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Primary outcome [2] 0 0
Substudy 1 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
Timepoint [2] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Primary outcome [3] 0 0
Substudy 2 Part 1a: Number of participants with dose-limiting toxicities (DLTs), treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
Timepoint [3] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Primary outcome [4] 0 0
Substudy 2 Part 1b: Number of participants with treatment-emergent adverse events, treatment-related adverse events, and serious adverse events
Timepoint [4] 0 0
From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
Secondary outcome [1] 0 0
Substudy 1 Part 1a and 1b: Overall Response Rate (ORR) for BGB-16673 and sonrotoclax
Timepoint [1] 0 0
Up to approximately 3 years
Secondary outcome [2] 0 0
Substudy 1 Part 1a and 1b: Duration of Response (DOR) for BGB-16673 and sonrotoclax
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [3] 0 0
Substudy 1 Part 1a and 1b: Time to Response (TTR) for BGB-16673 and sonrotoclax
Timepoint [3] 0 0
Up to approximately 3 years
Secondary outcome [4] 0 0
Substudy 1 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673 and sonrotoclax
Timepoint [4] 0 0
From Week 1 to Week 17
Secondary outcome [5] 0 0
Substudy 1 Part 1a: Maximum observed concentration (Cmax) of BGB-16673 and sonrotoclax
Timepoint [5] 0 0
From Week 1 to Week 17
Secondary outcome [6] 0 0
Substudy 1 Part 1a: Time to maximum concentration (Tmax) of BGB-16673 and sonrotoclax
Timepoint [6] 0 0
From Week 1 to Week 17
Secondary outcome [7] 0 0
Substudy 1 Part 1a: Terminal half-life (t1/2) of BGB-16673 and sonrotoclax
Timepoint [7] 0 0
From Week 1 to Week 17
Secondary outcome [8] 0 0
Substudy 1 Part 1a: Trough concentration (Ctrough) of BGB-16673 and sonrotoclax
Timepoint [8] 0 0
From Week 1 to Week 17
Secondary outcome [9] 0 0
Substudy 1 Part 1b: Number of patients with complete response or complete response with incomplete count recovery (CR/CRi) who achieve undetectable minimal residual disease (uMRD)
Timepoint [9] 0 0
Up to approximately 3 years
Secondary outcome [10] 0 0
Substudy 2 Part 1a and 1b: ORR for BGB-16673 and zanubrutinib
Timepoint [10] 0 0
Up to approximately 3 years
Secondary outcome [11] 0 0
Substudy 2 Part 1a and 1b: DOR for BGB-16673 and zanubrutinib
Timepoint [11] 0 0
Up to approximately 3 years
Secondary outcome [12] 0 0
Substudy 2 Part 1a and 1b: TTR for BGB-16673 and zanubrutinib
Timepoint [12] 0 0
Up to approximately 3 years
Secondary outcome [13] 0 0
Substudy 2 Part 1a: Area under the plasma concentration-time curve (AUC) of BGB-16673 and zanubrutinib
Timepoint [13] 0 0
From Week 1 to Week 17
Secondary outcome [14] 0 0
Substudy 2 Part 1a: Maximum observed concentration (Cmax) of BGB-16673 and zanubrutinib
Timepoint [14] 0 0
From Week 1 to Week 17
Secondary outcome [15] 0 0
Substudy 2 Part 1a: Time to maximum concentration (Tmax) of BGB-16673 and zanubrutinib
Timepoint [15] 0 0
From Week 1 to Week 17
Secondary outcome [16] 0 0
Substudy 2 Part 1a: Terminal half-life (t1/2) of BGB-16673 and zanubrutinib
Timepoint [16] 0 0
From Week 1 to Week 17
Secondary outcome [17] 0 0
Substudy 2 Part 1a: Trough concentration (Ctrough) of BGB-16673 and zanubrutinib
Timepoint [17] 0 0
From Week 1 to Week 17

Eligibility
Key inclusion criteria
Key

* Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF
* Confirmed diagnosis of a R/R B-cell malignancy
* Protocol-defined measurable disease
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
* Adequate organ function
* Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment
* Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, or 90 days after the last dose of sonrotoclax
* Substudy 2

* Bruton tyrosine kinase (BTK) inhibitor-naive, or
* Previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Treatment-naive B-cell malignancies
* Unable to comply with the requirements of the protocol
* Active leptomeningeal disease or uncontrolled, untreated brain metastasis
* Any malignancy = 2 years before first dose of study treatment except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively
* Autologous stem cell transplant = 3 months prior to screening or chimeric antigen T-cell therapy = 3 months prior to screening
* Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent
* Participants who have a history of severe allergic reactions or hypersensitivity to the active ingredient and excipients of BGB-16673, sonrotoclax, or zanubrutinib
* Substudy 1 Exclusion Criterion:

* Prior treatment with a B-cell lymphoma-2 (Bcl-2) inhibitor
* Substudy 2 Exclusion Criterion:

* Participants who discontinued prior zanubrutinib treatment due to intolerance

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2029
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St George Hospital - Kogarah
Recruitment hospital [2] 0 0
Mater Cancer Care Centre - South Brisbane
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 hospital [6] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
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 postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New Jersey
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
China
State/province [11] 0 0
Fujian
Country [12] 0 0
China
State/province [12] 0 0
Guangdong
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Zhejiang
Country [15] 0 0
Germany
State/province [15] 0 0
Dresden
Country [16] 0 0
Germany
State/province [16] 0 0
Jena
Country [17] 0 0
Germany
State/province [17] 0 0
Kiel
Country [18] 0 0
Germany
State/province [18] 0 0
Tuebingen
Country [19] 0 0
Germany
State/province [19] 0 0
Ulm
Country [20] 0 0
Italy
State/province [20] 0 0
Bologna
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
State/province [22] 0 0
Napoli
Country [23] 0 0
Italy
State/province [23] 0 0
Rozzano
Country [24] 0 0
Italy
State/province [24] 0 0
Verona
Country [25] 0 0
New Zealand
State/province [25] 0 0
Auckland
Country [26] 0 0
New Zealand
State/province [26] 0 0
Takapuna
Country [27] 0 0
Poland
State/province [27] 0 0
Gdansk
Country [28] 0 0
Poland
State/province [28] 0 0
Lublin
Country [29] 0 0
Poland
State/province [29] 0 0
Olsztyn
Country [30] 0 0
Poland
State/province [30] 0 0
Opole
Country [31] 0 0
Poland
State/province [31] 0 0
Warsaw

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
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Fax 0 0
Email 0 0
clinicaltrials@beigene.com
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?
IPD available at link: https://www.beigenemedical.com/medical-information-request


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/NCT06634589