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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
A Study of BGB-A3055, Alone and in Combination With Tislelizumab in Participants With Selected Advanced or Metastatic 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

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 phase (RDFE) of BGB-A3055 in combination with tislelizumab 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
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
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 (Dose Escalation): Objective Response Rate (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
Number of participants with anti-drug antibodies (ADAs) against tislelizumab
Timepoint [7] 0 0
Up to 2 Years
Secondary outcome [8] 0 0
Serum concentration of BGB-A3055 at specified time points
Timepoint [8] 0 0
Up to 2 Years
Secondary outcome [9] 0 0
Phase 1b (Dose Expansion): Progression-Free Survival (PFS)
Timepoint [9] 0 0
Up to 2 Years
Secondary outcome [10] 0 0
Phase 1b (Dose Expansion): Number of participants with adverse events (AEs)
Timepoint [10] 0 0
Up to 2 Years
Secondary outcome [11] 0 0
Phase 1b (Dose Expansion) CCR8 expression
Timepoint [11] 0 0
Up to 2 Years
Secondary outcome [12] 0 0
Phase 1b (Dose Expansion) PD-L1 expression
Timepoint [12] 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 and have adequate organ function.
3. Participants with histologically confirmed advanced or metastatic solid tumors associated with high CCR8 and who have previously received available standard systemic therapy or for whom treatment is not available or not tolerated and could not receive 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 the archival formalin-fixed paraffin-embedded (FFPE) tumor tissues (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.
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. Untreated chronic hepatitis B or chronic HBV carriers with HBV DNA = 500 IU/mL (or = 2500 copies/mL) at screening. Participants with active hepatitis C, and participants with HIV infection.

Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B can be enrolled. 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 .

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
1/02/2025
Actual
Sample size
Target
318
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
Iowa
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
China
State/province [4] 0 0
Chongqing
Country [5] 0 0
China
State/province [5] 0 0
Fujian
Country [6] 0 0
China
State/province [6] 0 0
Liaoning
Country [7] 0 0
China
State/province [7] 0 0
Tianjin
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
SaintHerblain

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
BeiGene
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/NCT05935098