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Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05767931
Collaborator
(none)
60
Enrollment
1
Location
24
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, single-center, non-randomized, non-controlled study

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Immunotherapy with immune-checkpoint inhibitors (ICIs) has enabled a leap forward in the treatment of various types of cancer within the past decade. However,only 12.46% of patients with cancer are expected to respond to ICIs.Our team have recently developed a multi-specific antibody technology platform for the microenvironment of solid tumors.

    In this study, we are going to study the tumor immune microenvironment of breast cancer patients by patient-derived organoids or PDX model，to design multi-specific antibody drugs for different tumor immune microenvironment，to look forward to improve the effectiveness of immunotherapy for breast cancer and solve the problem of drug resistance.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
    Anticipated Study Start Date :
    Mar 6, 2023
    Anticipated Primary Completion Date :
    Nov 6, 2024
    Anticipated Study Completion Date :
    Mar 6, 2025

    Outcome Measures

    Primary Outcome Measures

    1. antitumor rate of multi-specific antibody in patient-derived organoids and PDX model [24 months]

      Patient-derived organoids and PDX model

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Women between 18 and 70 years old；

    2. Primary lesion >2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination；

    3. Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments；

    4. Subjects signed informed consent；

    Exclusion Criteria:

    1. A history of prior or concomitant malignancies;

    2. Advanced stage breast cancer (stage IV)；

    3. Suspected or confirmed lesion was surgically removed；

    4. Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Cancer Hospital Beijing Beijing China 100142

    Sponsors and Collaborators

    • Peking University

    Investigators

    • Principal Investigator: Zhaoqing Fan, Breast center at Peking University Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University
    ClinicalTrials.gov Identifier:
    NCT05767931
    Other Study ID Numbers:
    • BC-P32
    First Posted:
    Mar 14, 2023
    Last Update Posted:
    Mar 14, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Mar 14, 2023