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A Study to Evaluate LBL-007 in Combination With Tislelizumab Plus Chemotherapy in Participants With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Sponsor
BeiGene (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06010303
Collaborator
(none)
116
Enrollment
2
Arms
22
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
116 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Sep 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: LBL-007

LBL-007 in combination with tislelizumab plus chemotherapy doublet.

Drug: LBL-007
LBL-007 will be administered at a standard dose intravenously.

Drug: Tislelizumab
Tislelizumab will be administered at a standard dose intravenously.
Other Names:
  • BGB-A317

    • Drug: Chemotherapy Doublet
    Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.
    Active Comparator: Tislelizumab and Chemotherapy

    Tislelizumab plus chemotherapy doublet.

    Drug: Tislelizumab
    Tislelizumab will be administered at a standard dose intravenously.
    Other Names:
  • BGB-A317

    • Drug: Chemotherapy Doublet
    Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate (ORR) [Approximately 14 months]

      Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.

    Secondary Outcome Measures

    1. Progression Free Survival (PFS) [Approximately 14 months]

      Time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

    2. Duration of Response (DOR) [Approximately 14 months]

      Time from the first determination of an overall response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first.

    3. Disease Control Rate (DCR) [Approximately 14 months]

      Percentage of participants whose BOR is CR, PR, and stable disease as assessed by the investigator per RECIST v1.1.

    4. Number of Participants with Adverse Events (AEs) [Approximately 14 months]

      Number of participants with AEs, including findings from physical examinations, electrocardiograms, and laboratory assessments according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Able to provide written informed consent and can agree to comply with the study requirements.

    • Participants with metastatic ESCC or unresectable, locally advanced ESCC.

    • Histologically confirmed diagnosis of ESCC.

    • Can provide a tumor sample.

    • At least 1 measurable lesion as defined by RECIST v1.1.

    • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

    Exclusion Criteria:

    • Prior treatment for advanced or metastatic ESCC within the past 6 months

    • Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator

    • Palliative radiation treatment for ESCC within the past 4 weeks

    • Participants with an esophageal/bronchial or esophageal/aorta fistula

    • Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • BeiGene

    Investigators

    • Study Director: Study Director, BeiGene

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT06010303
    Other Study ID Numbers:
    • BGB-A317-LBL-007-202
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Esophageal Squamous Cell Carcinoma
    Tislelizumab

    Study Results

    No Results Posted as of Aug 24, 2023