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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06803680




Registration number
NCT06803680
Ethics application status
Date submitted
27/01/2025
Date registered
25/03/2025

Titles & IDs
Public title
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1, Open-Label Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B455 in Patients With Selected Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
2024-512931-64-00
Secondary ID [2] 0 0
BGB-B455-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGB-B455

Experimental: Phase 1a: Dose Escalation and Safety Expansion - Sequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.

Experimental: Phase 1b: Dose Expansion - Recommended Dose(s) for Expansion (RDFE\[s\]) of BGB-B455 as monotherapy determined from Phase 1a will be evaluated for selected indications based on emerging data.


Treatment: Drugs: BGB-B455
Planned doses administered on specified days per protocol.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timepoint [1] 0 0
From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455
Timepoint [2] 0 0
Approximately 1 month
Primary outcome [3] 0 0
Phase 1a: RDFE of BGB-B455
Timepoint [3] 0 0
Approximately 1 month
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [4] 0 0
Approximately 18 months
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Approximately 18 months
Secondary outcome [2] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [2] 0 0
Approximately 18 months
Secondary outcome [3] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately 18 months
Secondary outcome [4] 0 0
Phase 1a and 1b: Time to Response (TTR)
Timepoint [4] 0 0
Approximately 18 months
Secondary outcome [5] 0 0
Phase 1a and 1b: Serum concentrations of BGB-B455
Timepoint [5] 0 0
Approximately 7 months
Secondary outcome [6] 0 0
Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BGB-B455
Timepoint [6] 0 0
Approximately 7 months
Secondary outcome [7] 0 0
Phase 1b: Progression-Free Survival (PFS)
Timepoint [7] 0 0
Approximately 18 months
Secondary outcome [8] 0 0
Phase 1b: Number of participants with AEs
Timepoint [8] 0 0
From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months
Secondary outcome [9] 0 0
Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-B455
Timepoint [9] 0 0
Approximately 4 months
Secondary outcome [10] 0 0
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-B455
Timepoint [10] 0 0
Approximately 4 months
Secondary outcome [11] 0 0
Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-B455
Timepoint [11] 0 0
Approximately 4 months
Secondary outcome [12] 0 0
Phase 1a and 1b: Trough Concentration (Ctrough) of BGB-B455
Timepoint [12] 0 0
Approximately 7 months
Secondary outcome [13] 0 0
Phase 1a and 1b: Apparent clearance (CL) of BGB-B455
Timepoint [13] 0 0
Approximately 4 months
Secondary outcome [14] 0 0
Phase 1a and 1b: Volume of distribution (Vd) of BGB-B455
Timepoint [14] 0 0
Approximately 4 months
Secondary outcome [15] 0 0
Phase 1a and 1b: Accumulation Ratio of BGB-B455
Timepoint [15] 0 0
Approximately 4 months
Secondary outcome [16] 0 0
Phase 1a and 1b: Terminal half-life (t1/2) of BGB-B455
Timepoint [16] 0 0
Approximately 4 months

Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated.
* Agreement for collection of formalin-fixed paraffin-embedded (FFPE) tumor tissue for central CLDN6 testing and other biomarker assessments.
* Tumor CLDN6 expression (CDLN6+) by central immunohistochemistry testing is required for Phase 1a dose escalation Cohort 5 and higher.
* = 1 measurable lesion as assessed by RECIST v1.1.
* Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior systemic anticancer therapy, including chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin), targeted therapy, and antibody drug conjugates (ADCs) that are standard or investigational agents (including herbal medicine or Chinese [or other country] patent medicines, = 14 days or 5 half-lives (whichever is shorter) before the first dose of study drug(s).
* Palliative radiation treatment or other locoregional therapies = 14 days before the first dose of study drug(s).
* Live vaccine = 28 days before the first dose of study drug(s). Vaccines for COVID-19 are allowed except for any live vaccine that may become available. Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
* Any major surgical procedure = 28 days before the first dose of study drug(s).
* History of prior = Grade 3 cytokine release syndrome (CRS).
* Participants with toxicities (because of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities).

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
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
Pennsylvania
Country [3] 0 0
United States of America
State/province [3] 0 0
South Dakota
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
China
State/province [5] 0 0
Shanghai

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
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT06803680