Urothelial carcinoma, breast cancer
Conditions
Interventions
The second stage:25 individuals were respectively injected with INR203 and FDG, and underwent PET/CT imaging
among them, 8 individuals provided blood and urine sample
The first stage:Inject INR203 and FDG separately, and then perform PET/CT imaging.
Sponsors
The First Affiliated Hospital, Jinan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years old or above; 2. ECOG score of 0 or 1 point; 3. Histopathological examination confirmed that the primary tumors were urothelial carcinomas (including bladder cancer, ureteral cancer, and renal pelvis cancer), breast cancer (ER-, PR-, Her2- type or HR+, Her2- type), etc., and for the participants for whom advanced metastatic lesions had been confirmed; 4. Applicable only to the second stage: Researchers assess participants who have at least one palpable tumor lesion that can be biopsied (acceptable to provide archived or fresh tumor tissue within 30 days prior to signing the ICF for Nectin-4 immunohistochemical testing); 5. The blood routine, liver and kidney function, and coagulation function tests meet the following criteria: hemoglobin > 80g/L; platelets > 50×10^9/L; (1) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 6 months; 7. Agree that from the date of signing the informed consent form to 3 months after the administration of the medication, contraceptive measures must be taken to avoid sperm donation/egg donation. 8. The participants/guardians were fully informed about the purpose and procedures of the trial, and were able to understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. The participants who were unable to complete the imaging examination as per the trial requirements as evaluated by the researchers; 2. Within 5 years prior to the first administration, having >= 2 types of malignant tumors, but excluding metastatic thyroid cancer, skin basal cell carcinoma or skin superficial squamous cell carcinoma, and superficial bladder cancer that have been adequately treated. 3. Before signing the informed consent form, one had participated in other interventional clinical trials and was within the 5 half-lives of the drug used in that trial, or was currently participating in other interventional clinical trials, or had participated in a clinical trial of radioactive treatment drugs before signing the informed consent form and the duration of drug discontinuation was less than 3 months from the date of discontinuation to the date of signing the informed consent form. 4. Within 24 hours before the administration of INR203 injection, the subject had received intravenous injection of iodine contrast agent, or had received any high-density oral contrast agent within 5 days (excluding those with no contrast agent residue in the intestinal tract as determined by the investigator; oral water-soluble contrast agents are acceptable); 5. It is planned to receive any anti-tumor treatment during the INR203 PET/CT and 18F-FDG PET/CT imaging procedures. 6. Known to be allergic to the active components of INR203 or 18F-FDG or any of its components; 7. Women planning to get pregnant, those who are pregnant or breastfeeding; 8. The researchers determined that there were any medical conditions or other circumstances that could affect safety, compliance, or might influence the research results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of detectable lesions on INR203 PET/CT at different imaging time points compared with 18F-FDG PET/CT in patients with advanced solid tumors including urothelial carcinoma and breast cancer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of intravenous INR203 injection, including adverse events, laboratory tests before and after administration, 12-lead electrocardiography, physical examination, and vital signs;Pharmacokinetic parameters and radiation dosimetry in whole blood/plasma/urine after intravenous INR203 injection;Correlation between tumor lesion SUVmax and Nectin-4 expression level assessed by immunohistochemistry in tumor tissues; | — |
Countries
China
Contacts
Public ContactWang Lu, Guo Zexiong
The First Affiliated Hospital, Jinan University
Outcome results
None listed