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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
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
Secondary ID [1] 0 0
2024-513280-11-00
Secondary ID [2] 0 0
BGB-C354-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Assessment method [1] 0 0
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
Timepoint [1] 0 0
Up to approximately 2 years
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-C354
Assessment method [2] 0 0
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
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
Assessment method [3] 0 0
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
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
Assessment method [4] 0 0
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).
Timepoint [4] 0 0
Up to approximately 2 years
Primary outcome [5] 0 0
Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-C354 alone and in combination with tislelizumab
Assessment method [5] 0 0
The RP2D of BGB-C354 will be determined based on safety, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Phase 1b: Progression Free Survival (PFS)
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Up to approximately 2 years
Secondary outcome [5] 0 0
Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events
Assessment method [5] 0 0
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
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Maximum observed plasma concentration (Cmax) for BGB-C354
Assessment method [6] 0 0
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Minimum observed plasma concentration (Cmin) for BGB-C354
Assessment method [7] 0 0
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Time to maximum plasma concentration (Tmax) for BGB-C354
Assessment method [8] 0 0
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Half-life (t1/2) for BGB-C354
Assessment method [9] 0 0
Timepoint [9] 0 0
Up to approximately 2 years
Secondary outcome [10] 0 0
Area under the concentration-time curve (AUC) for BGB-C354
Assessment method [10] 0 0
Timepoint [10] 0 0
Up to approximately 2 years
Secondary outcome [11] 0 0
Apparent clearance (CL/F) for BGB-C354
Assessment method [11] 0 0
Timepoint [11] 0 0
Up to approximately 2 years
Secondary outcome [12] 0 0
Apparent volume of distribution (Vz/F) for BGB-C354
Assessment method [12] 0 0
Timepoint [12] 0 0
Up to approximately 2 years
Secondary outcome [13] 0 0
Accumulation ratio for BGB-C354
Assessment method [13] 0 0
Timepoint [13] 0 0
Up to approximately 2 years
Secondary outcome [14] 0 0
Number of participants with anti-drug antibodies (ADAs) to BGB-C354
Assessment method [14] 0 0
Timepoint [14] 0 0
Up to approximately 2 years
Secondary outcome [15] 0 0
Serum concentration of BGB-C354
Assessment method [15] 0 0
Timepoint [15] 0 0
Up to approximately 2 years

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Guangxi
Country [7] 0 0
China
State/province [7] 0 0
Hubei
Country [8] 0 0
China
State/province [8] 0 0
Jilin
Country [9] 0 0
China
State/province [9] 0 0
Liaoning
Country [10] 0 0
China
State/province [10] 0 0
Sichuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Director
Address 0 0
Country 0 0
Phone 0 0
1.877.828.5568
Email 0 0
clinicaltrials@beigene.com
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.