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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06233942
Registration number
NCT06233942
Ethics application status
Date submitted
23/01/2024
Date registered
31/01/2024
Titles & IDs
Public title
Study of BG-C9074 as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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Scientific title
Phase 1a/1b Study of BG-C9074, an Antibody Drug Conjugate Targeting B7H4, as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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Secondary ID [1]
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2023-509958-65-00
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Secondary ID [2]
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BG-C9074-101
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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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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BG-C9074
Treatment: Drugs - Tislelizumab
Experimental: Phase 1a: Part A (Monotherapy Dose Escalation) - BG-C9074 monotherapy dose escalation
Experimental: Phase 1a: Part B (Monotherapy Safety Expansion) - BG-C9074 dose levels that have been determined to be safe and tolerable in Part A will be investigated.
Experimental: Phase 1a: Part C (Combination Therapy Dose Escalation) - BG-C9074 plus tislelizumab combination at the recommended dose for expansion (RDFE).
Experimental: Phase 1b: Monotherapy Dose Expansion - The monotherapy dose expansion phase will begin once the BG-C9074 monotherapy RDFE and dosing schedule have been determined from Parts A and B in Phase 1a.
Treatment: Drugs: BG-C9074
administered by intravenous infusion
Treatment: Drugs: Tislelizumab
administered by intravenous infusion
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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 findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
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Timepoint [1]
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Approximately 3 years
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Primary outcome [2]
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C9074
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Assessment method [2]
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defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 28% or the highest dose administered, respectively
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Timepoint [2]
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Approximately 18 months
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Primary outcome [3]
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Phase 1a: Recommended Dose for Expansion (RDFE) of BG-C9074.
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Assessment method [3]
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The potential RDFE(s) of BG-C9074 alone and in combination with tislelizumab will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and any other relevant data, as available
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Timepoint [3]
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Approximately 18 months
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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 (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
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Timepoint [4]
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Approximately 3 years
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Primary outcome [5]
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Phase 1b: Recommended Phase 2 dose (RP2D) of BG-C9074
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Assessment method [5]
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The RP2D of BG-C9074 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
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Timepoint [5]
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Approximately 30 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 (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
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Timepoint [1]
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Approximately 3 years
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
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Timepoint [2]
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Approximately 3 years
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Secondary outcome [3]
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Disease Control Rate (DCR)
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Assessment method [3]
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DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease.
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Timepoint [3]
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Approximately 3 years
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Secondary outcome [4]
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Clinical Benefit Rate (CBR)
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Assessment method [4]
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CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting = 24 weeks as assessed by investigator.
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Timepoint [4]
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Approximately 3 years
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Secondary outcome [5]
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Phase 1b: Progression Free Survival (PFS)
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Assessment method [5]
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PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
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Timepoint [5]
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Approximately 3 years
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Secondary outcome [6]
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Phase 1b: Number of Participants with AEs and SAEs
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Assessment method [6]
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Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
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Timepoint [6]
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Approximately 3 years
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Secondary outcome [7]
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Maximum observed plasma concentration (Cmax) for BG-C9074
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Assessment method [7]
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Timepoint [7]
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Approximately 3 years
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Secondary outcome [8]
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Minimum observed plasma concentration (Cmin) for BG-C9074
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Assessment method [8]
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Timepoint [8]
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Approximately 3 years
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Secondary outcome [9]
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Time to maximum plasma concentration (Tmax) for BG-C9074
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Assessment method [9]
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Timepoint [9]
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Approximately 3 years
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Secondary outcome [10]
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Half-life (t1/2) for BG-C9074
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Assessment method [10]
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Timepoint [10]
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Approximately 3 years
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Secondary outcome [11]
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Area under the concentration-time curve (AUC) for BG-C9074
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Assessment method [11]
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Timepoint [11]
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Approximately 3 years
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Secondary outcome [12]
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Apparent clearance (CL/F) for BG-C9074
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Assessment method [12]
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Timepoint [12]
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Approximately 3 years
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Secondary outcome [13]
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Apparent volume of distribution (Vz/F) for BG-C9074
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Assessment method [13]
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Timepoint [13]
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Approximately 3 years
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Secondary outcome [14]
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Accumulation ratio for BG-C9074
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Assessment method [14]
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Timepoint [14]
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Approximately 3 years
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Secondary outcome [15]
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Plasma concentrations for BG-C9074
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Assessment method [15]
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Timepoint [15]
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Approximately 3 years
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Secondary outcome [16]
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Number of participants with anti-drug antibodies (ADAs) to BG-C9074
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Assessment method [16]
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Timepoint [16]
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Approximately 3 years
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Secondary outcome [17]
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Serum concentration of BG-C0974
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Assessment method [17]
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Timepoint [17]
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Approximately 3 years
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Eligibility
Key inclusion criteria
1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
3. Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.
4. = 1 measurable lesion per RECIST v1.1.
5. Able to provide an archived tumor tissue sample.
6. Adequate organ function.
7. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for = 7 months after the last dose of study drug(s).
8. Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for = 4 months after the last dose of study drug(s).
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Minimum age
18
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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. Prior treatment with a B7H4-targeting antibody drug conjugates (ADC)
2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis
3. Any malignancy = 2 years before the first dose of study treatment(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. History of interstitial lung disease, = Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
5. Uncontrolled diabetes.
6. Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy = 14 days before the first dose of study treatment(s).
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
Parallel
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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
12/04/2024
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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
28/09/2027
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Macquarie University - North Ryde
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Recruitment hospital [2]
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Cancer Care Wollongong - Wollongong
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Recruitment hospital [3]
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Monash Health - Clayton
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Recruitment hospital [4]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment hospital [5]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2109 - North Ryde
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment postcode(s) [5]
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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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Maryland
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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 is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with tislelizumab in participants with advanced solid tumors. Participants will receive study drug(s) until progressive disease, unacceptable toxicity, withdrawal of consent, death, or another discontinuation criterion is met, whichever occurs first. The maximum length of receiving study drug(s) for a participant is up to 2 years.
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Trial website
https://clinicaltrials.gov/study/NCT06233942
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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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT06233942