solid tumors (including but not limited to breast cancer, bladder cancer, pancreatic cancer, cervical cancer, esophageal cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma)
Conditions
Interventions
Intravenous injection of one less dose of 68Ga-BRP-020063 injection:5 mCi (acceptable range 3~7 mCi)
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, regardless of gender; 2.Patients with a confirmed diagnosis of solid tumors (including but not limited to breast cancer, bladder cancer, pancreatic cancer, cervical cancer, esophageal cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma); 3. Agree to provide archived or freshly obtained tumor tissue samples (preferably within 2 years); 4. At least one measurable lesion as defined by RECIST 1.1; 5.Eastern Cooperative Oncology Group (ECOG) performance status score of 0–1; 6. Adequate organ function: Hematologic: white blood cell count >=3.0×10^9/L;absolute neutrophil count >=1.5×10^9/L, hemoglobin >=90 g/L, platelet count >=75×10^9/L; • Hepatic: total bilirubin =50 mL/min (Cockcroft-Gault formula); • Coagulation: prothrombin time <=1.5×ULN, activated partial thromboplastin time <=1.5×ULN, international normalized ratio <=1.5×ULN; 7. Subjects of reproductive potential voluntarily agree to use effective contraception during treatment and for 6 months after the last dose of the study drug (contraceptive methods include intrauterine device or intrauterine system, diaphragm, etc., for females; 11.condom use for males, and contraception must always be used strictly according to the product instructions and investigator guidance); 8. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously treated with drugs targeting Nectin-4 (including clinical trials); 2. Unable to undergo PET/CT examinations (including inability to lie flat, claustrophobia, fear of radiation, etc.); 3. Participated in drug or device clinical research within 4 weeks prior to initial dosing; 4. Suffering from severe or uncontrolled underlying diseases, including but not limited to: a) NYHA class II or higher congestive heart failure, or severe arrhythmias requiring medication; Severe cardiovascular/cerebrovascular or valvular diseases;Poorly controlled diabetes; 5. Unable to tolerate intravenous administration, or difficulty with venous blood collection (such as history of fainting from needles or blood); 6. Active infections within 4 weeks prior to initial dosing; 7. Women who are planning pregnancy, pregnant, or breastfeeding; 8. Allergic to radiation, or have other serious allergy history; 9.History of central nervous system metastasis with related symptoms; 10.Concurrent other malignant tumors; 11. Underwent general anesthesia surgery within 8 weeks prior to initial dosing; 12. Other conditions deemed by the investigator as unsuitable for inclusion in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Results Statistical Analysis;Incidence of AE and SAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistical Analysis of Pharmacokinetic Results;Statistical Analysis of PET Scan Results; | — |
Countries
China
Contacts
Public ContactLiyan Miao
The First Affiliated Hospital of Soochow University
Outcome results
None listed