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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
Date last updated
29/06/2025

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
Treatment: Drugs - Chemotherapy

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

Experimental: Phase 1b: Dose Expansion - Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.


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

Treatment: Drugs: Tislelizumab
Planned doses administered by intravenous infusion.

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) and Serious Adverse Events (SAEs)
Assessment method [1] 0 0
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Timepoint [1] 0 0
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Primary outcome [2] 0 0
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
Assessment method [2] 0 0
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Timepoint [2] 0 0
Approximately 1 month
Primary outcome [3] 0 0
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
Assessment method [3] 0 0
RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
Timepoint [3] 0 0
Approximately 1 month
Primary outcome [4] 0 0
Phase 1b: Overall Response Rate (ORR)
Assessment method [4] 0 0
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Timepoint [4] 0 0
Approximately 6 months
Secondary outcome [1] 0 0
Phase 1a: ORR
Assessment method [1] 0 0
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Timepoint [1] 0 0
Approximately 6 months
Secondary outcome [2] 0 0
Phase 1a and 1b: Duration of Response (DOR)
Assessment method [2] 0 0
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Timepoint [2] 0 0
Approximately 9 months
Secondary outcome [3] 0 0
Phase 1a and 1b: Disease Control Rate (DCR)
Assessment method [3] 0 0
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.
Timepoint [3] 0 0
Approximately 6 months
Secondary outcome [4] 0 0
Phase 1a and 1b: Clinical Benefit Rate (CBR)
Assessment method [4] 0 0
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting = 24 weeks as assessed by investigator.
Timepoint [4] 0 0
Approximately 6 months
Secondary outcome [5] 0 0
Phase 1b: Progression Free Survival (PFS)
Assessment method [5] 0 0
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Timepoint [5] 0 0
Approximately 9 months
Secondary outcome [6] 0 0
Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808
Assessment method [6] 0 0
Timepoint [6] 0 0
Approximately 1 month
Secondary outcome [7] 0 0
Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808
Assessment method [7] 0 0
Timepoint [7] 0 0
Approximately 6 months
Secondary outcome [8] 0 0
Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808
Assessment method [8] 0 0
Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.
Timepoint [8] 0 0
Approximately 1 month
Secondary outcome [9] 0 0
Phase 1a: Half-life (t1/2) for BGB-26808
Assessment method [9] 0 0
Timepoint [9] 0 0
Approximately 1 month
Secondary outcome [10] 0 0
Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808
Assessment method [10] 0 0
Timepoint [10] 0 0
Approximately 1 month
Secondary outcome [11] 0 0
Phase 1a: Apparent clearance (CL/F) for BGB-26808
Assessment method [11] 0 0
Timepoint [11] 0 0
Approximately 1 month
Secondary outcome [12] 0 0
Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808
Assessment method [12] 0 0
Timepoint [12] 0 0
Approximately 1 month
Secondary outcome [13] 0 0
Phase 1a: Accumulation ratio for BGB-26808
Assessment method [13] 0 0
Timepoint [13] 0 0
Approximately 1 month
Secondary outcome [14] 0 0
Phase 1b: Plasma concentrations of BGB-26808
Assessment method [14] 0 0
Timepoint [14] 0 0
Approximately 6 months
Secondary outcome [15] 0 0
Phase 1b: Number of Participants with AEs and SAEs
Assessment method [15] 0 0
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Timepoint [15] 0 0
From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months

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. Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
4. Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of = 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
5. = 1 measurable lesion per RECIST v1.1.
6. Able to provide an archived tumor tissue sample.
7. Adequate organ function.
8. 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, or for = 180 days after the last dose of chemotherapy.
9. 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, or for = 180 days after the last dose of chemotherapy.
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 anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
5. Active autoimmune diseases or history of autoimmune diseases that may relapse
6. 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).
7. 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).
8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
9. Uncontrolled diabetes.
10. 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
Randomised controlled 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
30/09/2027
Actual
Sample size
Target
217
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
Anhui
Country [8] 0 0
China
State/province [8] 0 0
Heilongjiang
Country [9] 0 0
China
State/province [9] 0 0
Hubei
Country [10] 0 0
China
State/province [10] 0 0
Liaoning
Country [11] 0 0
China
State/province [11] 0 0
Shandong
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
China
State/province [13] 0 0
Sichuan
Country [14] 0 0
China
State/province [14] 0 0
Zhejiang
Country [15] 0 0
New Zealand
State/province [15] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 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
Email 0 0
clinicaltrials@beigene.com
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/NCT05981703