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Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

Primary Purpose

Non-small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tislelizumab IV
Tislelizumab SC
Histology-Based Chemotherapy Doublet
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring lung cancer, non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Able to sign a written consent form, understand, and agree to comply with requirements of the study. Documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC. No prior systemic treatment for advanced or metastatic NSCLC, including but not limited to chemotherapy or targeted therapy. At least one measurable lesion as assessed by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) PS ≤ 1. Adequate organ function as indicated by laboratory tests. Exclusion Criteria: Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation). Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Active autoimmune diseases or history of autoimmune diseases that may relapse. Any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, 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 first dose of study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Part 1: Dose/Injection Site Exploration

    Part 2: Dose Expansion

    Arm Description

    Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.

    The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated.

    Outcomes

    Primary Outcome Measures

    Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC
    Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC
    Part 1: Bioavailability of Tislelizumab SC
    Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC
    Part 2: Accumulation ratio (Rac) of Tislelizumab SC
    Part 2: Elimination half-life (t1/2) of Tislelizumab SC
    Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v5.0]), timing, seriousness, and relationship to study therapy.

    Secondary Outcome Measures

    Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC
    Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by NCI-CTCAE v5.0), timing, seriousness, and relationship to study therapy.
    Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies
    Part 2: Overall Response Rate (ORR) of Tislelizumab SC
    ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
    Part 2: Duration of Response (DOR) of Tislelizumab SC
    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 due to any cause, whichever occurs first as assessed by the investigator.
    Part 2: Progression-Free Survival (PFS)
    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 due to any cause, whichever occurs first.

    Full Information

    First Posted
    October 16, 2023
    Last Updated
    October 18, 2023
    Sponsor
    BeiGene
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091943
    Brief Title
    Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer
    Official Title
    Phase 1 Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in the First-Line Treatment of Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    July 26, 2025 (Anticipated)
    Study Completion Date
    March 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    BeiGene

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer
    Keywords
    lung cancer, non-small cell lung cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Part 1: Dose/Injection Site Exploration
    Arm Type
    Experimental
    Arm Description
    Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype.
    Arm Title
    Part 2: Dose Expansion
    Arm Type
    Experimental
    Arm Description
    The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated.
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab IV
    Other Intervention Name(s)
    BGB-A317 IV
    Intervention Description
    Planned doses will be administered intravenously.
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab SC
    Other Intervention Name(s)
    BGB-A317 SC
    Intervention Description
    Planned doses will be administered via subcutaneous injection.
    Intervention Type
    Drug
    Intervention Name(s)
    Histology-Based Chemotherapy Doublet
    Intervention Description
    Chemotherapy Doublet 1: Cisplatin/carboplatin + pemetrexed. Chemotherapy Doublet 2: Carboplatin + paclitaxel/nab-paclitaxel. Choice of histology-based induction chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
    Primary Outcome Measure Information:
    Title
    Part 1 and 2: Area under the concentration-time curve (AUC) of Tislelizumab SC
    Time Frame
    Up to approximately 3.5 months
    Title
    Part 1 and 2: Concentration at the end of dosing interval (Ctrough) of Tislelizumab SC
    Time Frame
    Up to approximately 3.5 months
    Title
    Part 1: Bioavailability of Tislelizumab SC
    Time Frame
    Up to approximately 2 months
    Title
    Part 2: Maximum observed plasma concentration (Cmax) of Tislelizumab SC
    Time Frame
    Up to approximately 3.5 months
    Title
    Part 2: Accumulation ratio (Rac) of Tislelizumab SC
    Time Frame
    Up to approximately 3.5 months
    Title
    Part 2: Elimination half-life (t1/2) of Tislelizumab SC
    Time Frame
    Up to approximately 3.5 months
    Title
    Part 2: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Description
    Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v5.0]), timing, seriousness, and relationship to study therapy.
    Time Frame
    Up to approximately 27 months
    Secondary Outcome Measure Information:
    Title
    Part 1: Maximum observed concentration (Cmax) of Tislelizumab SC
    Time Frame
    Up to approximately 2 months
    Title
    Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
    Description
    Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by NCI-CTCAE v5.0), timing, seriousness, and relationship to study therapy.
    Time Frame
    Up to approximately 27 months
    Title
    Part 1 and 2: Number of Participants with Anti-Tislelizumab Antibodies
    Time Frame
    Up to 25 months
    Title
    Part 2: Overall Response Rate (ORR) of Tislelizumab SC
    Description
    ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as determined from tumor assessments by investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
    Time Frame
    Up to approximately 27 months
    Title
    Part 2: Duration of Response (DOR) of Tislelizumab SC
    Description
    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 due to any cause, whichever occurs first as assessed by the investigator.
    Time Frame
    Up to approximately 27 months
    Title
    Part 2: Progression-Free Survival (PFS)
    Description
    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 due to any cause, whichever occurs first.
    Time Frame
    Up to approximately 27 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Able to sign a written consent form, understand, and agree to comply with requirements of the study. Documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC. No prior systemic treatment for advanced or metastatic NSCLC, including but not limited to chemotherapy or targeted therapy. At least one measurable lesion as assessed by RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) PS ≤ 1. Adequate organ function as indicated by laboratory tests. Exclusion Criteria: Participants diagnosed with NSCLC that harbor a driver mutation (eg, EGFR-sensitizing mutation, ALK fusion oncogene, and BRAF V600E mutation or ROS1 mutation). Participant has received any Chinese herbal medicine or Chinese patent medicines used to control cancer within 14 days before first dose of study drug. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. Active autoimmune diseases or history of autoimmune diseases that may relapse. Any cancer ≤ 5 years before first dose of study drug except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, localized prostate cancer, 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 first dose of study drug. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Study Director
    Phone
    1.877.828.5568
    Email
    clinicaltrials@beigene.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Study Director
    Organizational Affiliation
    BeiGene
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

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