PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor
Conditions
Interventions
Trial group:Lukangsatuzumab (5 mg/kg, Q2W) combined with Tagolimab (900 mg, Q2W), intravenous infusion
Sponsors
Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18-75 years old; 2. HR+/HER2- breast cancer (BC), meeting the following conditions: (1) HR+/HER2-; 1. HER2- (IHC 0 or 1+); 2. IHC 2+ (FISH negative); 3. HR+ (ER and/or PR IHC showed >=1%); (2) Tumor stage: Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer; 3. Disease progression during or within 12 months after completion of adjuvant endocrine therapy based on a CDK4/6 inhibitor, or disease progression on CDK4/6 inhibitor treatment for metastatic disease; 4. PD-L1 positive (CPS >= 1); 5. At least one measurable target lesion as assessed by the investigator per RECIST 1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7. Life expectancy more than 12 weeks; 8. Adequate organ function, defined as: (1) Complete blood count: Neutrophil count >= 1.5×10^9/L; 2. Platelets >= 100×10^9/L; 3. Hemoglobin >= 9 g/dL; (2) Liver function: AST, ALT, and ALP = 60 ml/min (Cockcroft-Gault formula); (4) Coagulation function: INR, APTT, and PT = 50%; 9. For female participants of childbearing potential and male participants with reproductive potential, effective medical contraceptive measures must be implemented from the time of signing the informed consent until six months after the last administration; 10. Voluntary participation in the study with signed informed consent, demonstrated good compliance, and willingness to follow up as required.
Exclusion criteria
Exclusion criteria: 1. Received any of the following treatments in the advanced stage: (1) Chemotherapy; (2) Any drug treatment containing targeted topoisomerase I inhibitors, including antibody-drug conjugate (ADC) therapy; (3) Immune checkpoint inhibitors (e.g., anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, or any other treatment targeting tumor immune mechanisms; 2. Recurrence or metastasis occurring within 12 months after the last chemotherapy in the early stage; 3. Subjects with central nervous system (CNS) metastases. For subjects with brain metastases who have previously received local treatment, enrollment is permitted if they are clinically stable for at least 4 weeks prior to dosing and do not require glucocorticoids or anticonvulsants for at least 14 days; 4. History of other malignant tumors within 5 years prior to dosing (except for tumors cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.); 5. Presence of any of the following cardiovascular and cerebrovascular diseases or risk factors: (1) Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Grade 3 or 4 heart failure [according to the New York Heart Association (NYHA) classification (see Appendix 5 for details)], symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular and cerebrovascular diseases within 6 months prior to dosing; (2) History of myocardial diseases such as myocarditis, primary cardiomyopathy, or specific cardiomyopathy; (3) Any deep vein thrombosis within 3 months prior to dosing (enrollment is permitted if stabilized for >=2 weeks with low molecular weight heparin or similar efficacy drugs), peripheral arterial thromboembolic events, pulmonary embolism, or other severe thromboembolic events; (4) Presence of life-threatening major vascular diseases such as aortic aneurysm or aortic dissection aneurysm, or those requiring surgery within 6 months prior to dosing; 6. Uncontrolled systemic diseases as judged by the investigator: (1) Poorly controlled diabetes (fasting blood glucose >=10 mmol/L on two consecutive occasions); (2) Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg); (3) Presence of pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage (>1 time/week); 7. History of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia that cannot be excluded by imaging during screening; 8. Clinically severe lung impairment caused by concurrent pulmonary diseases, including but not limited to any underlying lung disease (such as pulmonary embolism within 3 months prior to dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or history of total pneumonectomy; 9. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess, or acute gastrointes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival Rate at 6 Months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Objective Response Rate;Disease Control Rate;Duration of Response;Overall Survival; | — |
Countries
China
Contacts
Public ContactXu Fei
Sun Yat-sen University Cancer Center (Sun Yat-sen University Tumor Hospital, Sun Yat-sen University Institute of Oncology)
Outcome results
None listed