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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05981703




Registration number
NCT05981703
Ethics application status
Date submitted
31/07/2023
Date registered
8/08/2023

Titles & IDs
Public title
A Study Investigating BGB-26808 Alone or 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 HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
CTR20240210
Secondary ID [2] 0 0
BGB-A317-26808-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced 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-26808
Treatment: Drugs - Tislelizumab

Experimental: Dose Escalation - Phase 1a: Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.

Experimental: Dose Expansion - Phase 1b: The recommended dose for expansion (RDFE) for BGB-26808 (alone or in combination with tislelizumab) from Phase 1a will be evaluated.


Treatment: Drugs: BGB-26808
Planned doses administered orally as a tablet daily.

Treatment: Drugs: Tislelizumab
Planned doses 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
Approximately 3 years
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
Timepoint [2] 0 0
Approximately 1.5 years
Primary outcome [3] 0 0
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
Timepoint [3] 0 0
Approximately 1.5 years
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Phase 1a: ORR
Timepoint [1] 0 0
Approximately 2 years
Secondary outcome [2] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Phase 1a and 1b: Clinical Benefit Rate (CBR)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Phase 1b: Progression Free Survival (PFS)
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808
Timepoint [6] 0 0
Approximately 4 years
Secondary outcome [7] 0 0
Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808
Timepoint [7] 0 0
Approximately 4 years
Secondary outcome [8] 0 0
Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808
Timepoint [8] 0 0
Approximately 4 years
Secondary outcome [9] 0 0
Phase 1a: Half-life (t1/2) for BGB-26808
Timepoint [9] 0 0
Approximately 4 years
Secondary outcome [10] 0 0
Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808
Timepoint [10] 0 0
Approximately 4 years
Secondary outcome [11] 0 0
Phase 1a: Apparent clearance (CL/F) for BGB-26808
Timepoint [11] 0 0
Approximately 4 years
Secondary outcome [12] 0 0
Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808
Timepoint [12] 0 0
Approximately 4 years
Secondary outcome [13] 0 0
Phase 1a: Accumulation ratio for BGB-26808
Timepoint [13] 0 0
Approximately 4 years
Secondary outcome [14] 0 0
Phase 1b: Plasma concentrations of BGB-26808
Timepoint [14] 0 0
Approximately 4 years
Secondary outcome [15] 0 0
Phase 1b: Number of Participants with AEs and SAEs
Timepoint [15] 0 0
Approximately 3 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 = 1.
3. Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have been previously treated.
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 = 90 days after the last dose of BGB-26808 or for = 120 days after the last dose of tislelizumab.
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 = 90 days after the last dose of BGB-26808 or for = 120 days after the last dose of tislelizumab.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
2. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. Any malignancy = 3 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).
6. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication = 14 days before the first dose of study treatment(s).
7. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
8. Uncontrolled diabetes.
9. 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
Other
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
7/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Southside Cancer Care - Miranda
Recruitment hospital [2] 0 0
Macquarie University - North Ryde
Recruitment hospital [3] 0 0
Icon Cancer Centre Kurralta Park - Kurralta Park
Recruitment hospital [4] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
2109 - North Ryde
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
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
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
China
State/province [7] 0 0
Heilongjiang
Country [8] 0 0
China
State/province [8] 0 0
Hubei
Country [9] 0 0
China
State/province [9] 0 0
Liaoning
Country [10] 0 0
China
State/province [10] 0 0
Shandong
Country [11] 0 0
China
State/province [11] 0 0
Shanghai
Country [12] 0 0
China
State/province [12] 0 0
Zhejiang
Country [13] 0 0
New Zealand
State/province [13] 0 0
Auckland

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/NCT05981703