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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05935098
Registration number
NCT05935098
Ethics application status
Date submitted
26/06/2023
Date registered
7/07/2023
Date last updated
31/05/2024
Titles & IDs
Public title
A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic Solid Tumors
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Scientific title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-A3055, Alone and in Combination With Tislelizumab in Patients With Selected Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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2023-505322-34-00
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Secondary ID [2]
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BGB-A317-A3055-101
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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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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-A3055
Treatment: Drugs - Tislelizumab
Experimental: Phase 1a Part A: Dose Escalation (BGB-A3055 Monotherapy) - Different groups of participants will receive increasing doses of BGB-A3055 alone to determine the most appropriate dosage levels.
Experimental: Phase 1a Part B: Dose Escalation (BGB-A3055 + tislelizumab) - Different groups of participants will receive increasing doses of BGB-A3055 in combination with tislelizumab to determine the most appropriate dosage levels.
Experimental: Phase 1b (Dose Expansion): - Participants will receive the recommended dose for expansion phase (RDFE) of BGB-A3055 in combination with tislelizumab to provide additional information on the safety, tolerability, and potential benefits of the recommended dose.
Treatment: Drugs: BGB-A3055
Administered intravenously
Treatment: Drugs: Tislelizumab
Administered intravenously
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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)
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Assessment method [1]
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, and NCI-CTCAE v5.0.
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Timepoint [1]
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Up to 2 Years
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Primary outcome [2]
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Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055
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Assessment method [2]
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The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30%
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Timepoint [2]
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Up to 2 Years
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Primary outcome [3]
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Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055
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Assessment method [3]
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The RDFEs of BGB-A3055, alone and in combination with tislelizumab will be determined based on relevant data.
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Timepoint [3]
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Up to 2 Years
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Primary outcome [4]
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Phase 1b (Dose Expansion): Objective Response Rate (ORR)
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Assessment method [4]
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Defined as the proportion of participants with best overall response (BOR) of a complete response (CR) or partial response (PR) as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [4]
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Up to 2 Years
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Secondary outcome [1]
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Phase 1a (Dose Escalation): Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with partial or complete response, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [1]
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Up to 2 Years
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Secondary outcome [2]
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Time to Response (TTR)
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Assessment method [2]
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Defined as the time from the date of the first administration of study drug(s) to the first determination of an objective response.as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [2]
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Up to 2 Years
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Secondary outcome [3]
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Duration of Response (DoR)
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Assessment method [3]
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Defined as the time from the first determination of an objective response until the first documentation of disease progression or death due to any cause, whichever occurs first, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [3]
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Up to 2 Years
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Secondary outcome [4]
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Disease Control Rate (DCR)
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Assessment method [4]
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Defined as the proportion of participants with BOR of a CR, PR, or stable disease as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [4]
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Up to 2 Years
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Secondary outcome [5]
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Clinical Benefit Rate (CBR)
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Assessment method [5]
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Defined as the proportion of participants with BOR of a CR, PR, or stable disease lasting = 24 weeks as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [5]
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Up to 2 Years
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Secondary outcome [6]
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Number of participants with anti-drug antibodies (ADAs) against BGB-A3055
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Assessment method [6]
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Timepoint [6]
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Up to 2 Years
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Secondary outcome [7]
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Number of participants with anti-drug antibodies (ADAs) against tislelizumab
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Assessment method [7]
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Timepoint [7]
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Up to 2 Years
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Secondary outcome [8]
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Serum concentration of BGB-A3055 at specified time points
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Assessment method [8]
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Timepoint [8]
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Up to 2 Years
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Secondary outcome [9]
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Phase 1b (Dose Expansion): Progression-Free Survival (PFS)
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Assessment method [9]
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defined as the time from the date of the first administration of study drug(s) to the date of the first documentation of disease progression or death due to any cause, whichever occurs first, as determined from tumor assessments by the investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Timepoint [9]
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Up to 2 Years
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Secondary outcome [10]
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Phase 1b (Dose Expansion): Number of participants with adverse events (AEs)
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Assessment method [10]
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Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, physical examination findings, and electrocardiogram results.
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Timepoint [10]
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Up to 2 Years
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Secondary outcome [11]
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Phase 1b (Dose Expansion) CCR8 expression
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Assessment method [11]
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Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab, and their association with clinical efficacy.
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Timepoint [11]
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Up to 2 Years
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Secondary outcome [12]
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Phase 1b (Dose Expansion) PD-L1 expression
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Assessment method [12]
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Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab, and their association with clinical efficacy.
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Timepoint [12]
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Up to 2 Years
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Eligibility
Key inclusion criteria
1. Age=18 years on the day of signing the informed consent form (ICF) (or the legal age
of consent in the jurisdiction in which the study is taking place, whichever is
older).
2. All participants are also required to demonstrate an ECOG Performance Status score
of=1 and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors
associated with high CCR8 and who have previously received available standard systemic
therapy or for whom treatment is not available or not tolerated and could not receive
any prior therapy targeting CCR8.
4. >=1 Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Participants should be able to provide the archival formalin-fixed paraffin-embedded
(FFPE) tumor tissues (as block or unstained slides) or fresh biopsy if there is no
archival tissue at baseline. For selected cohorts, participants should be willing to
provide post-treatment fresh biopsy at specified timepoints.
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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
1. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
2. Active autoimmune diseases or history of autoimmune diseases that may relapse
3. 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 (eg, resected basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
4. Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA = 500 IU/mL (or =
2500 copies/mL) at screening. Participants with active hepatitis C, and participants
with HIV infection.
Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable
hepatitis B can be enrolled. Participants with a negative HCV antibody test result at
screening or a positive HCV antibody test result followed by a negative HCV RNA test
result at screening are eligible to participate. Participants with treated HIV
infection may be included if certain criteria are met.
5. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung
diseases including pulmonary fibrosis, or acute lung diseases .
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
Single group
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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
21/08/2023
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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
1/02/2025
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Actual
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Sample size
Target
318
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Chris Obrien Lifehouse - Camperdown
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Recruitment hospital [2]
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Icon Cancer Care South Brisbane - South Brisbane
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Recruitment hospital [3]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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6009 - Nedlands
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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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Iowa
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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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New Jersey
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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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Texas
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Country [4]
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France
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State/province [4]
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Bordeaux
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Country [5]
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France
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State/province [5]
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Paris
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Country [6]
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France
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State/province [6]
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SaintHerblain
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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
This study aims to test the safety, tolerability, and preliminary anti-tumor activity of
BGB-A3055, either alone or in combination with Tislelizumab in participants with advanced or
metastatic solid tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05935098
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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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BeiGene
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05935098
Download to PDF