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

Peking University60 enrolled

Overview

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

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

Conditions

Invasive Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.；

Locations (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

antitumor rate of multi-specific antibody in patient-derived organoids and PDX model

Patient-derived organoids and PDX model

Time frame: 24 months

Central Contacts

Zhaoqing Fan, MD

CONTACT

+86-10-88197838 zhqfan@sina.com

Data from ClinicalTrials.gov

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