Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07439120
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years, regardless of gender;
2. Patients with a confirmed diagnosis of advanced metastatic solid tumor (preferably urothelial carcinoma, followed by breast cancer);
3. Willing to provide archived or freshly biopsied tumor tissue specimens (recommended within the past 2 years);
4. Performance status (ECOG) score of 0-1;
5. Adequate organ function:
* Complete Blood Count: White blood cell count ≥ 3.0 × 10⁹/L, neutrophil count ≥ 1.5 × 10⁹/L, hemoglobin ≥ 90 g/L, platelet count ≥ 75 × 10⁹/L;
* Liver function: Total bilirubin ≤ 2.5 × ULN, alanine aminotransferase ≤ 3 × ULN, aspartate aminotransferase ≤ 3 × ULN;
* Renal function: Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula);
* Coagulation function: Prothrombin time ≤ 1.5 × ULN, activated partial thromboplastin time ≤ 1.5 × ULN, international normalized ratio ≤ 1.5 × ULN;
6. Subjects of childbearing potential must voluntarily adopt effective contraception during the treatment period and for 6 months after the last dose of the investigational drug (for females);
7. Willing to participate in this trial and sign an informed consent form.
Exclusion Criteria:
1. Previous treatment with Nectin-4-targeted drugs (including clinical trials);
2. Inability to complete PET/CT or SPECT/CT examinations (including inability to lie flat, claustrophobia, radiophobia, etc.);
3. Participation in drug or device clinical studies within 4 weeks prior to the first dose;
4. Presence of severe or uncontrolled underlying diseases, including but not limited to:
1. NYHA Class II or higher congestive heart failure, or severe arrhythmia requiring medication;
2. Severe cardiovascular/cerebrovascular or valvular diseases;
3. Poorly controlled diabetes or hypertension;
5. Inability to tolerate intravenous administration or difficulty with venipuncture (e.g., history of needle or blood phobia);
6. Active infection within 4 weeks prior to the first dose;
7. Women who are planning pregnancy, currently pregnant, or breastfeeding;
8. Allergy to radioactive rays or other severe allergic history;
9. History of neurological metastasis with associated symptoms;
10. Concurrent other malignancies;
11. Undergone general anesthesia surgery within 4 weeks prior to the first dose;
12. Other conditions deemed by the investigator as unsuitable for inclusion in the clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07439120
Study Brief:
Protocol Section:
NCT07439120