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

Not yet recruiting

• Conditions: Invasive Breast Cancer

• Registration Number: NCT05767931
• Lead Sponsor: Peking University

Brief Summary

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

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 Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Study Start: 2023-03-06
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-14
• Primary Completion: 2024-11-06
• Study Completion: 2025-03-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model	24 months	Patient-derived organoids and PDX model

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China