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

March 2, 2023 updated by: Peking University
This is a prospective, single-center, non-randomized, non-controlled study

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital
        • Sub-Investigator:
          • Zhaorong Guo, PhD

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

Sampling Method

Non-Probability Sample

Study Population

invasive breast cancer

Description

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.；

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model
Time Frame: 24 months
Patient-derived organoids and PDX model
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

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

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 (Anticipated)

March 6, 2023

Primary Completion (Anticipated)

November 6, 2024

Study Completion (Anticipated)

March 6, 2025

Study Registration Dates

First Submitted

March 1, 2023

First Submitted That Met QC Criteria

March 2, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC-P32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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