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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05935098
Registration number
NCT05935098
Ethics application status
Date submitted
26/06/2023
Date registered
7/07/2023
Date last updated
21/05/2025
Titles & IDs
Public title
BGB-A3055 Alone and in Combination With Tislelizumab in Participants With 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
Treatment: Drugs - Chemotherapy
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 (RDFE) of BGB-A3055 in combination with tislelizumab with or without chemotherapy 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
Treatment: Drugs: Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
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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) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the American Society for Transplantation and Cellular Therapy \[ASTCT\] consensus grading system for cytokine release syndrome \[CRS\]), and including findings from laboratory assessments, electrocardiograms (ECGs), and physical examinations, and that meet protocol-defined dose-limiting toxicity (DLT) criteria.
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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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MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%. MAD is defined as the highest dose administered.
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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 alone or in combination with tislelizumab
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Assessment method [3]
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The RDFEs of BGB-A3055, alone or in combination with tislelizumab will be determined based on biological effectiveness taking preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration.
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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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ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator 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: ORR
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Assessment method [1]
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ORR is defined as the percentage of participants who had 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 [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 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 to the time of first documentation of radiographic progression, as determined from tumor assessments by the investigators per RECIST v1.1, or death from any cause, whichever comes first.
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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 percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease as determined from tumor assessments by the investigators per 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 percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) as determined from tumor assessments by the investigators per 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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Serum concentration of BGB-A3055 at specified time points
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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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Phase 1b: Progression-Free Survival (PFS)
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Assessment method [8]
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Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as determined from tumor assessments by investigators per RECIST v1.1.
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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: Number of participants with adverse events (AEs)
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Assessment method [9]
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Number of participants with TEAEs and SAEs graded according to the NCI-CTCAE version 5.0 and the ASTCT consensus grading system for CRS, and including findings from laboratory assessments, ECGs, and physical examinations.
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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: Association of CCR8 expression with clinical efficacy
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Assessment method [10]
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Evaluated from participant-derived tumor tissue(s) obtained before and/or after treatment with BGB-A3055 in combination with tislelizumab with or without chemotherapy, and their association with clinical efficacy.
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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: Association of PD-L1 expression with clinical efficacy
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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 with or without chemotherapy, and their association with clinical efficacy.
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Timepoint [11]
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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 within 3 days before the first dose of study drug(s) and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received adequate available standard systemic therapy or for whom treatment is not available or not tolerated and who have not received 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 archival tumor tissue samples (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.
6. Females of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control for the duration of the study, and for = 120 days after the last dose of BGB-A3055 or tislelizumab (whichever is later), or up to 9 months after the last dose of chemotherapy, whichever is later. Females of childbearing potential must also have a negative urine or serum pregnancy test result = 7 days before the first dose of study drug(s).
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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. Participants with hepatitis B infection with HBV DNA = 500 IU/mL (or = 2500 copies/mL). Participants with active hepatitis C, and participants with HIV infection.
Note: Participants with chronic hepatitis B infection or resolved hepatitis B infection (HBV DNA < 500 IU/mL or < 2500 copies/mL) and considered stable are eligible. 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.
6. Grade 3 immune-mediated adverse events on prior immune-oncology agent.
7. Cardiovascular risk factors, including but not limited to pulmonary embolism = 28 days or history of acute myocardial infarction or heart failure = 6 months before the first dose of study drug(s).
8. Uncontrolled diabetes.
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
Active, not 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
31/03/2027
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Actual
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Sample size
Target
263
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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 Centre 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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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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Iowa
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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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New Jersey
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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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Chongqing
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Country [7]
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China
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State/province [7]
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Fujian
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Country [8]
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China
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State/province [8]
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Henan
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Country [9]
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China
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State/province [9]
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Jiangsu
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Country [10]
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China
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State/province [10]
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Liaoning
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Country [11]
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China
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State/province [11]
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Shanxi
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Country [12]
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China
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State/province [12]
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Tianjin
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Country [13]
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China
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State/province [13]
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Zhejiang
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Country [14]
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China
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State/province [14]
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Shanghai
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Country [15]
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France
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State/province [15]
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Bordeaux
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Country [16]
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France
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State/province [16]
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Paris
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Country [17]
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France
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State/province [17]
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SaintHerblain
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Country [18]
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Korea, Republic of
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State/province [18]
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Gyeonggi-do
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Country [19]
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Korea, Republic of
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State/province [19]
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Seoul Teugbyeolsi
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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 evaluate how safe and well-tolerated the treatment is, how the body processes it, how it works on the tumors, and whether it shows early signs of fighting cancer in people with certain advanced or metastatic solid tumors. Key details of the study include: * The study is expected to last about 36 months. * Participants will receive treatment until they either no longer benefit from the treatment, experience side effects that are too severe, or choose to stop participating.
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Trial website
https://clinicaltrials.gov/study/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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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/NCT05935098
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