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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05767931
Enrollment
60
Registered
2023-03-14
Start date
2023-03-06
Completion date
2025-03-06
Last updated
2023-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Breast Cancer

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.

Interventions

None listed

Sponsors

Peking University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
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.;

Design outcomes

Primary

MeasureTime frameDescription
antitumor rate of multi-specific antibody in patient-derived organoids and PDX model24 monthsPatient-derived organoids and PDX model

Countries

China

Contacts

Primary ContactZhaoqing Fan, MD
zhqfan@sina.com+86-10-88197838

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026