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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06422520
Registration number
NCT06422520
Ethics application status
Date submitted
15/05/2024
Date registered
21/05/2024
Date last updated
22/06/2025
Titles & IDs
Public title
A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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Scientific title
A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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Secondary ID [1]
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2024-513280-11-00
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Secondary ID [2]
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BGB-C354-101
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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 - BGB-C354
Treatment: Drugs - Tislelizumab
Experimental: Phase 1a: Part A (Monotherapy Dose Escalation) - BGB-C354 monotherapy doses at sequentially increasing levels.
Experimental: Phase 1a: Part B (Safety Expansion) - Participants will enroll at safe dose levels recommended by the Safety Monitoring Committee (SMC) for further evaluation.
Experimental: Phase 1b: Part C (Monotherapy Expansion) - BGB-C354 will be administered at the recommended dose for expansion (RDFE).
Experimental: Phase 1b: Part D (Combination Therapy Expansion) - BGB-C354 and tislelizumab will be adminsitered at doses determined by the SMC.
Treatment: Drugs: BGB-C354
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 characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria
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Timepoint [1]
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Up to approximately 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-C354
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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 30% or the highest dose administered, respectively
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Timepoint [2]
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Up to approximately 2 years
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Primary outcome [3]
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Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
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Assessment method [3]
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The potential RDFE(s) of BGB-C354 will be determined based on the MTD or MAD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available
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Timepoint [3]
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Up to approximately 2 years
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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 Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
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Timepoint [4]
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Up to approximately 2 years
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Primary outcome [5]
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Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab
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Assessment method [5]
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The RP2D of BGB-C354 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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Up to approximately 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 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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Up to approximately 2 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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Up to approximately 2 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 as determined from tumor assessments by the investigator using RECIST v1.1.
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Timepoint [3]
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Up to approximately 2 years
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Secondary outcome [4]
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Phase 1b: Progression Free Survival (PFS)
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Assessment method [4]
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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.determined from tumor assessments by the investigator using RECIST v1.1.
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Timepoint [4]
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Up to approximately 2 years
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Secondary outcome [5]
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Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events
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Assessment method [5]
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Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v 5.0\]), timing, seriousness, and relationship to study drug(s); physical examinations; electrocardiograms (ECGs); and laboratory assessments as needed; and adverse events meeting protocol-defined dose-limitingtoxicity (DLT) criteria
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Timepoint [5]
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Up to approximately 2 years
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Secondary outcome [6]
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Maximum observed plasma concentration (Cmax) for BGB-C354
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Assessment method [6]
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Timepoint [6]
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Up to approximately 2 years
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Secondary outcome [7]
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Minimum observed plasma concentration (Cmin) for BGB-C354
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Assessment method [7]
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Timepoint [7]
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Up to approximately 2 years
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Secondary outcome [8]
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Time to maximum plasma concentration (Tmax) for BGB-C354
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Assessment method [8]
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Timepoint [8]
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Up to approximately 2 years
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Secondary outcome [9]
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Half-life (t1/2) for BGB-C354
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Assessment method [9]
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Timepoint [9]
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Up to approximately 2 years
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Secondary outcome [10]
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Area under the concentration-time curve (AUC) for BGB-C354
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Assessment method [10]
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Timepoint [10]
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Up to approximately 2 years
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Secondary outcome [11]
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Apparent clearance (CL/F) for BGB-C354
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Assessment method [11]
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Timepoint [11]
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Up to approximately 2 years
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Secondary outcome [12]
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Apparent volume of distribution (Vz/F) for BGB-C354
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Assessment method [12]
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Timepoint [12]
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Up to approximately 2 years
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Secondary outcome [13]
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Accumulation ratio for BGB-C354
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Assessment method [13]
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Timepoint [13]
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Up to approximately 2 years
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Secondary outcome [14]
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Number of participants with anti-drug antibodies (ADAs) to BGB-C354
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Assessment method [14]
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Timepoint [14]
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Up to approximately 2 years
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Secondary outcome [15]
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Serum concentration of BGB-C354
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Assessment method [15]
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Timepoint [15]
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Up to approximately 2 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 of 0 or 1.
3. Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors, whose cancer is not amenable to therapy with curative intent:
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
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. Prior treatment with B7H3-targeted therapy.
2. For Part B and Phase 1b: Prior treatment with antibody drug conjugates (ADCs) with topoisomerase I inhibitor payload (for Phase 1b, unless otherwise specified for specific cohorts).
3. Participants with spinal cord compressions, active leptomeningeal disease or uncontrolled, or untreated brain metastasis
4. 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).
5. History of interstitial lung disease, = Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen at baseline
6. Uncontrolled diabetes, or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium levels despite standard medical management = 14 days before the first dose of study drug(s).
7. 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
5/07/2024
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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
30/11/2026
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Actual
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Sample size
Target
62
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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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Westmead Hospital - Westmead
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Recruitment hospital [2]
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St Vincents Hospital Melbourne - Fitzroy
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Recruitment hospital [3]
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The Alfred Hospital - Melbourne
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Recruitment hospital [4]
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One Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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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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Massachusetts
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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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Missouri
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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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China
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State/province [5]
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Beijing
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Country [6]
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China
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State/province [6]
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Guangxi
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Country [7]
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China
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State/province [7]
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Hubei
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Country [8]
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China
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State/province [8]
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Jilin
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Country [9]
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China
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State/province [9]
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Liaoning
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Country [10]
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China
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State/province [10]
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Sichuan
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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, Phase 1a/1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of BGB-C354 alone and in combination with tislelizumab in participants with advanced solid tumors. Study details include: * The study will be conducted in 2 phases: Phase 1a (Monotherapy Dose Escalation and Safety Expansion) and Phase 1b (Dose Expansion). * The visit frequency will be approximately every 21 days during study treatment. * The study duration is estimated to be approximately 5 years.
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Trial website
https://clinicaltrials.gov/study/NCT06422520
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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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clinicaltrials@beigene.com
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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/NCT06422520
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