triple-negative breast cancer
Conditions
Interventions
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures; 2. Male or female, aged 18 to 75 years (including boundary value); 3. Unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, ER, PR, HER-2 are all negative. Negative ER and PR were defined as: IHCER = 12 months; 5. All subjects should accept fresh tumor lesion biopsy during the screening period (bone biopsy, fine-needle biopsy and pleural and ascites samples are not accepted; subjects with only the only target lesion available for biopsy are not accepted), Obtain enough qualified tumor tissue samples for the analysis of biomarkers (including PD-L1 expression level) in the cohort; If the subject is unable to undergo biopsy, the tumor sample or unstained section (3-5µm ) for the corresponding biomarker analysis; If the subject is unable to provide a specimen that meets the above requirements due to special reasons, the subject can participate in the screening after evaluation and approval by the sponsor; 6. Sufficient organ function; 7. The Eastern Cooperative Oncology Group (ECOG) score of physical status is 0-1; 8. Expected survival period >= 12 weeks; 9. According to the RECIST1.1 standard, the subject has at least one measurable tumor lesion; 10. Fertile female subjects must have a negative blood pregnancy result within 7 days before starting the study treatment for the first time, and be willing to maintain abstinence or take medically prescribed medicines from the signing of the informed consent form to 6 months after the end of the last medication. Approved high-efficiency contraceptive methods (such as IUDs, condoms); 11. Male subjects are willing to maintain abstinence or take medically approved high-efficiency contraceptive measures from the signing of the informed consent form to 6 months after the end of the last medication, and do not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; 2. The adverse reactions of previous anti-tumor treatments have not recovered to Grade 1 or below according to the evaluation of CTCAE 5.0 (except for the toxicity with no safety risk, such as alopecia and stable hypothyroidism after hormone replacement therapy); 3. Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF; 4. Have a history of pulmonary fibrosis in the past, or have interstitial pneumonia, pneumoconiosis, chemical pneumonia and other diseases with severely impaired lung function (asymptomatic interstitial changes of lung caused by radiotherapy, chemotherapy or other reasons (such as smoking, etc.) are acceptable); 5. Have received the following treatments or drugs before starting the study treatment: (1) Have received immunotherapy, nitrosourea and mitomycin C within 6 weeks before starting the study and treatment; Or received oral fluorouracil and small molecule targeted drugs 2 weeks before the start of study treatment or within 5 half-lives of drugs (whichever is longer); Or received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before the start of research and treatment; Or received palliative radiotherapy within 7 days before starting the study treatment; Or have received other chemotherapy, radical/extensive radiotherapy, endocrine therapy, biotherapy (tumor vaccine, cytokine or growth factor for tumor control) and other anti-tumor treatments or any unlisted trial drugs within 28 days before starting the study treatment; (2) Having undergone major organ surgery (excluding puncture biopsy) or had obvious trauma within 4 weeks before the first use of the study drug, or needing to undergo elective surgery during the trial; (3) There are unhealed wounds, ulcers or fractures with clinical significance; (4) Corticosteroids (prednisone > 10 mg/day or equivalent dosage of similar drugs) were received within 14 days before the start of study treatment, excluding topical corticosteroids, intranasal corticosteroids, intraarticular corticosteroids or inhaled corticosteroids. Corticosteroids are allowed to be used for a short time (= 7 days within 2 weeks before starting the study and treatment; 6. There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis; 7. Those who have active infection and currently need intravenous anti-infection treatment; 8. There are any active autoimmune diseases or autoimmune diseases with a history and expected recurrence (such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for subjects with clinically stable autoimmune thyroid disease and type I diabetes; 9. In the 5 years before the start of research and treatment, he had other active malignant tum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate assessed by Independent Review Committee;Incidence and severity of treatment-related adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Overall Survival;Pharmacokinetics;PM8002 anti-drug antibody;Duration of response;Progression-free survival; | — |
Countries
China
Contacts
Public ContactJiong Wu
Fudan University Shanghai Cancer Center
Outcome results
None listed