Advanced Epithelial Cancer
Conditions
Interventions
0.2mg/kg:BAT8003,0.2mg/kg,intravenous infusion
0.5mg/kg:BAT8003,0.5mg/kg,intravenous infusion
1mg/kg:BAT8003,1mg/kg,intravenous infusion
2mg/kg:BAT8003,2mg/kg,intravenous infusion
4mg/kg:BAT8003,4mg/kg,intravenous infusion
6mg/kg:BAT8003,6mg/kg,intravenous infusion
8mg/kg :BAT8003,8mg/kg,intravenous infusion
10mg/kg:BAT8003,10mg/kg,intravenous infusion
Amplification group:BAT8003,intravenous infusion,choose one proper dose from 1?2?4?6?8?10mg/kg
Sponsors
The Second Affiliated Hospital Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The patient or his legal representative signs the informed consent form and fully understands the content, process of the study and possible adverse reactions of the study, and is willing to follow up and image evaluation according to the time specified in the protocol; 2) Aged 18 to 75 years, gender is not limited; 3) Patients with advanced epithelial cancer (including breast cancer, non-small cell lung cancer, urothelial cancer, etc.) who are ineffective, unable to receive, or absent from standard treatment, histologically or cytologically confirmed; 4) Can provide 5-10 blank pathological sections for pathology and Trop2 expression level detection; and confirm the expression of Trop2 by immunohistochemistry (Trop2 expression level is required to be 2+ or above in the expansion stage); 5) At least one tumor with measurable lesions according to the standard of RECIST (Evaluation Standard for Solid Tumor Efficacy) version 1.1; 6) The US Eastern Cooperative Oncology Group (ECOG) scores 0 to 1 points for physical status; 7) Expected survival period = 3 months; 8) Laboratory test indicators: Blood system: Neutrophil absolute value (NEU) = 1.5x10^9 / L Platelet count (PLT) = 100 x10^9/L Hemoglobin (HB) = 90g / L Liver: Total bilirubin (TBIL) = 1.5 ULN When there is no liver metastasis, Glutamic Oxalacetic Transaminase (AST) = 2.5 ULN Glutamic Pyruvic Transaminase (ALT) = 2.5 ULN When there is liver metastasis, Glutamic Oxalacetic Transaminase (AST) = 5.0 ULN Glutamic Pyruvic Transaminase (ALT) = 5.0 ULN Kidney: Creatinine (Cr) = 1.5ULN Urea nitrogen (BUN) =1.5ULN Coagulation: International normalized ratio (INR) = 1.5ULN Activated partial thromboplastin time (APTT) = 1.5ULN (except for therapeutic anticoagulant drugs) 9) Echocardiographic examination of left ventricular ejection fraction (LVEF) = 50%; 10) The treatment for solid cancer has been completed for at least 3 weeks, and has basically recovered from the adverse reactions of previous treatment (=1 grade according to CTCAE5.0 standard, except for hair loss); 11) Fertile Female test negative for blood pregnancy test within 7 days before the planned first study drug treatment
Exclusion criteria
Exclusion criteria: The patient will be excluded, if meets any of the following conditions: 1) Have active hepatitis B (HBV) or hepatitis C (HCV) or syphilis; 2) History of immunodeficiency, including positive for human immunodeficiency virus (HIV), or other acquired, congenital immunodeficiency disease, or history of organ transplantation; 3) Other active infections of clinical significance, based on investigator's judgment; 4) Other concurrent, severe, or uncontrollable systemic diseases (such as clinically significant metabolic diseases, poor wound healing, ulcers, etc.); 5) History of moderate or severe dyspnea due to advanced malignancy or its complications or severe pulmonary primary disease, or the need for continuous oxygen therapy, or current interstitial lung disease (ILD) Or pneumonia; 6) Cardiovascular abnormalities according to any of the following definitions within 6 months prior to enrollment: Grade = 3 symptomatic congestive heart failure (CHF) according to CTCAE version 5.0, or New York Heart Association (NYHA) criteria = 2, history of symptomatic congestive heart failure, history of transmural myocardial infarction, history of unstable angina, or severe arrhythmia, severe block, uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastole pressure > 110 mm Hg), or other clinically significant cardiovascular diseases; 7) The brain or other central nervous system metastasis symptom; Radiation or surgical treatment with central nervous system or brain metastases or within 1 month prior to first administration; 8) There are = 2 grade peripheral neuropathy (CTCAE version 5.0 classification); 9) Participated in and received other clinical trials within 4 weeks prior to enrollment; 10) Major surgical treatment within 4 weeks prior to enrollment and not fully recovered; 11) Used of strong CYP3A4 inhibitors and have not undergone circulatory clearance (less than 3 elimination half-lives) prior to administration of the first clinical study drug, or may require the combination of strong CYP3A4 inhibitors during the study period; 12) Known allergy to the test drug component, or it is suspected that it may be allergic; 13) Pregnant or lactating women; 14) Alcohol abuse, drug abuse or history of drug abuse in the past 6 months; 15) The investigator believes the patient is not suitable for this trail because of other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;DLT;RP2D;PK; | — |
Secondary
| Measure | Time frame |
|---|---|
| ADA;PD; | — |
Countries
China
Contacts
Public ContactJian Huang
The Second Affiliated Hospital Zhejiang University School of Medicine
Outcome results
None listed