- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981703
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
April 23, 2024 updated by: BeiGene
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
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors.
The main purpose of this study is to explore the recommended dosing for BGB-26808.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Study Director
- Phone Number: 1.877.828.5568
- Email: clinicaltrials@beigene.com
Study Locations
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New South Wales
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Miranda, New South Wales, Australia, 2228
- Recruiting
- Southside Cancer Care
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South Australia
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Kurralta Park, South Australia, Australia, 5037
- Recruiting
- Ashford Cancer Centre Research
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Western Australia
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Nedlands, Western Australia, Australia, 6009
- Recruiting
- Linear Clinical Research
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Hubei
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Wuhan, Hubei, China, 430079
- Recruiting
- Hubei Cancer Hospital
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Shandong
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Jining, Shandong, China, 272000
- Recruiting
- Jining No Peoples Hospital
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Shanghai
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Shanghai, Shanghai, China, 200433
- Recruiting
- Shanghai Pulmonary Hospital
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-
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Auckland, New Zealand, 1023
- Recruiting
- Auckland City Hospital
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Recruiting
- John Theurer Cancer Center Hackensack University Medical Center
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Texas
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Houston, Texas, United States, 77030-4009
- Recruiting
- The University of Texas MD Anderson Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have been previously treated.
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
- Adequate organ function.
- 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.
- 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.
Exclusion Criteria:
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- 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).
- 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).
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
- Uncontrolled diabetes.
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation
Phase 1a: Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
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Planned doses administered orally as a tablet daily.
Planned doses administered by intravenous infusion.
Other Names:
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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.
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Planned doses administered orally as a tablet daily.
Planned doses administered by intravenous infusion.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Approximately 3 years
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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.
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Approximately 3 years
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
Time Frame: Approximately 1.5 years
|
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 30%.
MAD is defined as the highest dose administered if MTD is not reached.
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Approximately 1.5 years
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Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
Time Frame: Approximately 1.5 years
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RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
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Approximately 1.5 years
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Phase 1b: Overall Response Rate (ORR)
Time Frame: Approximately 3 years
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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.
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Approximately 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1a: ORR
Time Frame: Approximately 2 years
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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.
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Approximately 2 years
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Phase 1a and 1b: Duration of Response (DOR)
Time Frame: Approximately 3 years
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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.
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Approximately 3 years
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Phase 1a and 1b: Disease Control Rate (DCR)
Time Frame: Approximately 3 years
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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.
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Approximately 3 years
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Phase 1a and 1b: Clinical Benefit Rate (CBR)
Time Frame: Approximately 3 years
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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.
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Approximately 3 years
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Phase 1b: Progression Free Survival (PFS)
Time Frame: Approximately 3 years
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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.
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Approximately 3 years
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Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808
Time Frame: Approximately 4 years
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Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab.
Single-dose and steady-state PK parameters.
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Approximately 4 years
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Phase 1a: Half-life (t1/2) for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1a: Apparent clearance (CL/F) for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1a: Accumulation ratio for BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1b: Plasma concentrations of BGB-26808
Time Frame: Approximately 4 years
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Approximately 4 years
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Phase 1b: Number of Participants with AEs and SAEs
Time Frame: Approximately 3 years
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Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
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Approximately 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Study Director, BeiGene
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
July 31, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BGB-A317-26808-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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