Development of Multi-specific Antibodies Based on Immune Microenvironment of Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- antitumor rate of multi-specific antibody in patient-derived organoids and PDX model
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women between 18 and 70 years old；
- •Primary lesion >2cm on imaging examination, or suspected axillary lymph node metastasis on imaging examination；
- •Previous not received preoperative radiotherapy, chemotherapy, endocrine therapy, immunotherapy, or other anticancer treatments；
- •Subjects signed informed consent；
Exclusion Criteria
- •A history of prior or concomitant malignancies;
- •Advanced stage breast cancer (stage IV)；
- •Suspected or confirmed lesion was surgically removed；
- •Patients were accompanied by severe organic diseases such as heart and cerebral disease, and liver and kidney disease.；
Outcomes
Primary Outcomes
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model
Time Frame: 24 months
Patient-derived organoids and PDX model
Secondary Outcomes
No secondary outcomes reported