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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03666143




Registration number
NCT03666143
Ethics application status
Date submitted
21/08/2018
Date registered
11/09/2018

Titles & IDs
Public title
A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Participants With Advanced Solid Tumors
Scientific title
A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
CTR20181404
Secondary ID [2] 0 0
BGB-900-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sitravatinib
Treatment: Drugs - Tislelizumab

Experimental: Sitravatinib + Tislelizumab - Sitravatinib 120 mg was administered orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks


Treatment: Drugs: Sitravatinib
Administered orally as a capsule

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [1] 0 0
Up to approximately 4 years and 2 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to approximately 4 years and 2 months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to approximately 4 years and 2 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to approximately 4 years and 2 months
Secondary outcome [4] 0 0
Progression-free Survival (PFS)
Timepoint [4] 0 0
Up to approximately 4 years and 2 months
Secondary outcome [5] 0 0
Maximum Plasma Concentration (Cmax) for Sitravatinib
Timepoint [5] 0 0
Predose and up to 24 hours post dose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21); 21 days per cycle
Secondary outcome [6] 0 0
Time to Maximum Plasma Concentration (Tmax) for Sitravatinib
Timepoint [6] 0 0
Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle
Secondary outcome [7] 0 0
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib
Timepoint [7] 0 0
Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle
Secondary outcome [8] 0 0
Clearance After Oral Administration (CL/F) for Sitravatinib
Timepoint [8] 0 0
Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle
Secondary outcome [9] 0 0
Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib
Timepoint [9] 0 0
Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle
Secondary outcome [10] 0 0
Observed Accumulation Ratio (Ro) for AUC0-tau for Sitravatinib
Timepoint [10] 0 0
Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle
Secondary outcome [11] 0 0
Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib
Timepoint [11] 0 0
Predose and up to 24 hours post dose on C1D1 and C1D21; 21 days per cycle

Eligibility
Key inclusion criteria
1. Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the Schedule of Assessments
2. Age = 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
3. At least 1 measurable lesion as defined by RECIST v1.1
4. Provide archival tumor tissue (formalin-fixed paraffin-embedded block [FFPE] with tumor tissue or unstained slides), if available.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
6. Adequate hematologic and end-organ function
7. Participants with inactive/asymptomatic carrier, chronic, or active hepatitis B virus (HBV) must have HBV deoxyribonucleic acid (DNA) < 500 IU/mL (or 2500 copies/mL) at Screening
8. Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and = 120 days after the last dose of study drugs and have a negative serum pregnancy test = 7 days of first dose of study drugs
9. Non-sterile 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 study drugs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unacceptable toxicity on prior anti-PD-1/PD-L1 treatment
2. Active leptomeningeal disease or uncontrolled brain metastasis
3. Active autoimmune diseases or history of autoimmune diseases that may relapse
4. Any active malignancy = 2 years
5. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before first dose of study drugs
6. History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases, including pulmonary fibrosis, acute lung diseases, etc.
7. Severe chronic or active infections (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy, within 14 days prior to first dose of study drugs
8. Known history of human immunodeficiency virus (HIV) infection
9. Participants with active hepatitis C infection
10. Any major surgical procedure requiring general anesthesia = 28 days before first dose of study drugs
11. Prior allogeneic stem cell transplantation or organ transplantation
12. Hypersensitivity to tislelizumab or sitravatinib, to any ingredient in the formulation, or to any component of the container
13. Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring within 6 months before first dose of study drugs
14. Concurrent participation in another therapeutic clinical trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2023
Sample size
Target
Accrual to date
Final
216
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Icon Cancer Foundation - South Brisbane
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Nucleus Network - Melbourne
Recruitment hospital [6] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Fujian
Country [3] 0 0
China
State/province [3] 0 0
Guangdong
Country [4] 0 0
China
State/province [4] 0 0
Henan
Country [5] 0 0
China
State/province [5] 0 0
Hubei
Country [6] 0 0
China
State/province [6] 0 0
Jiangsu
Country [7] 0 0
China
State/province [7] 0 0
Jilin
Country [8] 0 0
China
State/province [8] 0 0
Liaoning
Country [9] 0 0
China
State/province [9] 0 0
Shandong
Country [10] 0 0
China
State/province [10] 0 0
Tianjin
Country [11] 0 0
China
State/province [11] 0 0
Zhejiang

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03666143