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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
31/01/2025
Date last updated
22/06/2025
Titles & IDs
Public title
A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors
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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
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Secondary ID [1]
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2024-512931-64-00
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Secondary ID [2]
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BGB-B455-101
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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:
Advanced Solid Tumor
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Metastatic 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-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.
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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 with adverse events (AEs) and serious adverse events (SAEs)
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Assessment method [1]
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Number of participants with AEs and SAEs, including laboratory abnormalities, and AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined adverse events of special interest (AESI) criteria.
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Timepoint [1]
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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
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Primary outcome [2]
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455
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Assessment method [2]
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MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
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Timepoint [2]
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Approximately 1 month
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Primary outcome [3]
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Phase 1a: RDFE of BGB-B455
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Assessment method [3]
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RDFE of BGB-B455 will be determined based upon the MTD or MAD.
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Timepoint [3]
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Approximately 1 month
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Primary outcome [4]
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Phase 1b: Overall Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR), as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR must be confirmed by repeat assessments.
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Timepoint [4]
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Approximately 18 months
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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 with best overall response of CR or PR, as determined from tumor assessments by investigator per RECIST v1.1. CR and PR must be confirmed by repeat assessments.
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Timepoint [1]
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Approximately 18 months
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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 confirmed objective response to documented disease progression or death, whichever occurs first, as determined from tumor assessments by investigator per RECIST v1.1.
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Timepoint [2]
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Approximately 18 months
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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 who achieve CR, PR, or stable disease, as determined from tumor assessments by investigator per RECIST v1.1.
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Timepoint [3]
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Approximately 18 months
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Secondary outcome [4]
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Phase 1a and 1b: Time to Response (TTR)
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Assessment method [4]
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TTR is defined as the time from the date of the first administration of study drug to the first confirmed response, as determined from tumor assessments by investigator per RECIST v1.1.
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Timepoint [4]
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Approximately 18 months
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Secondary outcome [5]
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Phase 1a and 1b: Serum concentrations of BGB-B455
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Assessment method [5]
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Timepoint [5]
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Approximately 7 months
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Secondary outcome [6]
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Phase 1a and 1b: Number of participants with anti-drug antibodies (ADAs) to BGB-B455
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Assessment method [6]
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Timepoint [6]
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Approximately 7 months
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Secondary outcome [7]
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Phase 1b: Progression-Free Survival (PFS)
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Assessment method [7]
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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, whichever occurs first, as determined from tumor assessments by investigator per RECIST v1.1.
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Timepoint [7]
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Approximately 18 months
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Secondary outcome [8]
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Phase 1b: Number of participants with AEs
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Assessment method [8]
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Number of participants with AEs, including physical examinations, electrocardiograms (ECGs), and laboratory assessments as indicated.
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Timepoint [8]
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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
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Secondary outcome [9]
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Phase 1a and 1b: Area under the concentration-time curve (AUC) of BGB-B455
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Assessment method [9]
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Timepoint [9]
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Approximately 4 months
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Secondary outcome [10]
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Phase 1a and 1b: Maximum observed plasma concentration (Cmax) of BGB-B455
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Assessment method [10]
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Timepoint [10]
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Approximately 4 months
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Secondary outcome [11]
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Phase 1a and 1b: Time to reach maximum observed plasma concentration (Tmax) of BGB-B455
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Assessment method [11]
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Timepoint [11]
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Approximately 4 months
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Secondary outcome [12]
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Phase 1a and 1b: Trough Concentration (Ctrough) of BGB-B455
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Assessment method [12]
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Timepoint [12]
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Approximately 7 months
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Secondary outcome [13]
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Phase 1a and 1b: Apparent clearance (CL) of BGB-B455
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Assessment method [13]
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Timepoint [13]
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Approximately 4 months
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Secondary outcome [14]
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Phase 1a and 1b: Volume of distribution (Vd) of BGB-B455
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Assessment method [14]
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Timepoint [14]
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Approximately 4 months
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Secondary outcome [15]
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Phase 1a and 1b: Accumulation Ratio of BGB-B455
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Assessment method [15]
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Timepoint [15]
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Approximately 4 months
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Secondary outcome [16]
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Phase 1a and 1b: Terminal half-life (t1/2) of BGB-B455
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Assessment method [16]
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Timepoint [16]
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Approximately 4 months
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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.
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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
* 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.
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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
Recruiting
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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
18/03/2025
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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
30/10/2027
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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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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Liverpool Hospital - Liverpool
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Recruitment hospital [3]
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Mater Cancer Care Centre - South Brisbane
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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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2170 - Liverpool
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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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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Florida
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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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Pennsylvania
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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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South Dakota
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Country [4]
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United States of America
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State/province [4]
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Texas
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Country [5]
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United States of America
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State/province [5]
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Washington
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Country [6]
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China
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State/province [6]
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Beijing
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Country [7]
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China
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State/province [7]
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Guangdong
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Country [8]
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China
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State/province [8]
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Jiangxi
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Country [9]
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China
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State/province [9]
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Shanghai
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Country [10]
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China
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State/province [10]
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Shanxi
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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
The goal of this clinical trial is to learn if BGB-B455 can treat advanced or metastatic solid tumors expressing claudin 6 (CLDN6), a protein that is found on some tumors. The main questions it aims to answer are: * What is the recommended dosing for BGB-B455? * What medical problems do participants have when taking BGB-B455? The study has two parts: * Phase 1a: dose escalation and safety expansion * Phase 1b: dose expansion
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Trial website
https://clinicaltrials.gov/study/NCT06803680
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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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Study Director
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Address
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Country
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Phone
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1.877.828.5568
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Fax
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Email
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[email protected]
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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
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