Her 2 negative advanced breast cancer
Conditions
Interventions
Experimental group:MW11 injection
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed metastatic or locally advanced unresectable Her2-negative breast cancer, defined as Her2-negative (Wolff et al, 2018): (1) IHC0 or 1+; (2) IHC2+ and in situ hybridization (ISH) without Her2 expansion (validated dual-probe ISH: Her2/CEP17 ratio =2.0 and = 3 months; 8. The subject must have adequate organ function. The following laboratory tests during the screening period should be performed within 7 days before enrollment and dosing, and meet the following criteria (Not receiving blood transfusion, erythropoietin (EPO), granulocyte colony stimulating factor (G-CSF), or other relevant medical support within 7 days prior to testing): (1) Hematology: neutrophil count >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 90 g/L; (2) Renal function: serum creatinine or calculated creatinine clearance = 30 mL/min (Cockcroft-Gault formula); (3) Liver function: total bilirubin <= 1.5 ULN (total bilirubin <= 3 ULN in subjects with Gilbert syndrome or liver metastases), ALT, AST <= 2.5 ULN (in subjects with liver metastases <= 5 ULN), ALP <= 2.5 ULN (<= 5ULN in subjects with liver metastases or bone metastases); (4) Coagulation function: INR or PT <= 1.5 ULN, APTT <= 1.5 ULN; 9. The subject agrees to collect tumor biopsy specimens during the screening period, and/or has provided recently obtained (biopsy specimens from non-radioactive areas within 2 years), formalin-fixed, paraffin-embedded tissue blocks or unstained tumor tissue slides containing tumor tissue suitable for biomarker determination; 10. The subjects can understand the informed consent form, participate voluntarily and sign the informed consent form; 11. According to the evaluation by the investigator, they can comply with the requirements of this program; 12. Female subjects of childbearing potential or male subjects with partners of childbearing potential agree to use highly effective contraception from 7 days before the first dose until 24 weeks after the dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
Exclusion criteria
Exclusion criteria: 1. Patients with untreated active brain metastases or meningeal metastases; patients were allowed to enroll if their brain metastases were treated and the metastases were stable (Brain imaging examinations at least 4 weeks before the first dose show stable lesions, and no need for steroids or radiotherapy for brain metastases within 28 days before enrollment, and no new neurological symptoms, or neurological symptoms have returned to baseline levels) and there was no evidence of new or enlarged brain metastases; 2. Moderate to massive pleural effusion, ascites, and pericardial effusion that cannot be controlled by appropriate interventions; 3. Uncontrolled hypercalcemia (calcium ion >1.5 mmol/L; or calcium >12 mg/dL) or symptomatic hypercalcemia requires continuous bisphosphonate treatment; 4. Combined with other malignant tumors within 5 years before the first administration, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-basal invasive bladder cancer, localized low-risk prostate cancer (Patients defined as stage = 150/100 mmHg), symptomatic cardiac insufficiency (NYHA II-IV), left ventricular ejection fraction (LVEF) 470 msec (Fridericia method correction), refractory hypokalemia, long QT syndrome, atrial fibrillation with resting heart rate > 100 bpm or severe valvular disease, medically significant history of arrhythmias); 6. History of interstitial pneumonia, idiopathic pulmonary fibrosis and organizing pneumonia; 7. Patients with severe infection within 1 month prior to screening or any active infection requiring systemic treatment within 2 weeks prior to the first dose; 8. Past or current autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis with polyangiitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis), autoimmune hepatitis, systemic sclerosis (scleroderma, etc.), Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain-Barre syndrome), etc. Exceptions include: Type 1 diabetes, hypothyroidism stable on hormone replacement therapy (including hypothyroidism due to autoimmune thyroid disease), psoriasis or vitiligo not requiring systemic treatment; 9. Organ transplantation or allogeneic hematopoietic stem cell transplantation; 10. There are other diseases such as cardiovascular system, respiratory system, digestive system, endocrine system, reproductive system that may affect the research process or results; 11. Previously received immune checkpoint blockade or T cell costimulatory drug therapy or therapeutic vaccine, etc., including but not limited to PD-1, PD-L1, CTLA4, LAG3, CD137, etc.; 12. Patients who have received systemic anti-tumor therapy within 2 weeks before the first dose, including chemotherapy, immunotherapy, hormone therapy, biological therapy (cytokines or growth factors that control cancer progression); 13. Patients who have received Chinese patent medicines, Chinese herbal medicines or Chinese medicine preparations w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Duration of Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Progression-Free Survival Rate;Clinical Benefit Rate;Overall Survival Rate; | — |
Countries
China
Contacts
Public ContactMa Fei
Chinese Academy of Medical Sciences Cancer Hospital
Outcome results
None listed