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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

Titles & IDs
Public title
BGB-A3055 Alone and in Combination With Tislelizumab in Participants With Solid Tumors
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
Secondary ID [1] 0 0
2023-505322-34-00
Secondary ID [2] 0 0
BGB-A317-A3055-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
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.
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)
Timepoint [1] 0 0
Up to 2 Years
Primary outcome [2] 0 0
Phase 1a: Maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A3055
Timepoint [2] 0 0
Up to 2 Years
Primary outcome [3] 0 0
Phase 1a: Recommended dose for expansion (RDFE) of BGB-A3055 alone or in combination with tislelizumab
Timepoint [3] 0 0
Up to 2 Years
Primary outcome [4] 0 0
Phase 1b (Dose Expansion): Objective Response Rate (ORR)
Timepoint [4] 0 0
Up to 2 Years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Up to 2 Years
Secondary outcome [2] 0 0
Time to Response (TTR)
Timepoint [2] 0 0
Up to 2 Years
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to 2 Years
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
Up to 2 Years
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR)
Timepoint [5] 0 0
Up to 2 Years
Secondary outcome [6] 0 0
Number of participants with anti-drug antibodies (ADAs) against BGB-A3055
Timepoint [6] 0 0
Up to 2 Years
Secondary outcome [7] 0 0
Serum concentration of BGB-A3055 at specified time points
Timepoint [7] 0 0
Up to 2 Years
Secondary outcome [8] 0 0
Phase 1b: Progression-Free Survival (PFS)
Timepoint [8] 0 0
Up to 2 Years
Secondary outcome [9] 0 0
Phase 1b: Number of participants with adverse events (AEs)
Timepoint [9] 0 0
Up to 2 Years
Secondary outcome [10] 0 0
Phase 1b: Association of CCR8 expression with clinical efficacy
Timepoint [10] 0 0
Up to 2 Years
Secondary outcome [11] 0 0
Phase 1b: Association of PD-L1 expression with clinical efficacy
Timepoint [11] 0 0
Up to 2 Years

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

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
Single group
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
21/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/03/2027
Actual
Sample size
Target
263
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Icon Cancer Centre South Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 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
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
China
State/province [6] 0 0
Chongqing
Country [7] 0 0
China
State/province [7] 0 0
Fujian
Country [8] 0 0
China
State/province [8] 0 0
Henan
Country [9] 0 0
China
State/province [9] 0 0
Jiangsu
Country [10] 0 0
China
State/province [10] 0 0
Liaoning
Country [11] 0 0
China
State/province [11] 0 0
Shanxi
Country [12] 0 0
China
State/province [12] 0 0
Tianjin
Country [13] 0 0
China
State/province [13] 0 0
Zhejiang
Country [14] 0 0
China
State/province [14] 0 0
Shanghai
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Paris
Country [17] 0 0
France
State/province [17] 0 0
SaintHerblain
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Gyeonggi-do
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Seoul Teugbyeolsi

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
[email protected]
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