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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

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)
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
Timepoint [2] 0 0
Up to approximately 2 years
Primary outcome [3] 0 0
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-C354
Timepoint [3] 0 0
Up to approximately 2 years
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
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
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Up to approximately 2 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 2 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to approximately 2 years
Secondary outcome [4] 0 0
Phase 1b: Progression Free Survival (PFS)
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
Timepoint [5] 0 0
Up to approximately 2 years
Secondary outcome [6] 0 0
Maximum observed plasma concentration (Cmax) for BGB-C354
Timepoint [6] 0 0
Up to approximately 2 years
Secondary outcome [7] 0 0
Minimum observed plasma concentration (Cmin) for BGB-C354
Timepoint [7] 0 0
Up to approximately 2 years
Secondary outcome [8] 0 0
Time to maximum plasma concentration (Tmax) for BGB-C354
Timepoint [8] 0 0
Up to approximately 2 years
Secondary outcome [9] 0 0
Half-life (t1/2) for BGB-C354
Timepoint [9] 0 0
Up to approximately 2 years
Secondary outcome [10] 0 0
Area under the concentration-time curve (AUC) for BGB-C354
Timepoint [10] 0 0
Up to approximately 2 years
Secondary outcome [11] 0 0
Apparent clearance (CL/F) for BGB-C354
Timepoint [11] 0 0
Up to approximately 2 years
Secondary outcome [12] 0 0
Apparent volume of distribution (Vz/F) for BGB-C354
Timepoint [12] 0 0
Up to approximately 2 years
Secondary outcome [13] 0 0
Accumulation ratio for BGB-C354
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
Timepoint [14] 0 0
Up to approximately 2 years
Secondary outcome [15] 0 0
Serum concentration of BGB-C354
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
5/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2026
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
One Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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