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:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT07164950
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years Histologically or cytologically confirmed advanced malignancy (including but not limited to urothelial carcinoma) eligible for MMAE-containing ADC therapy (e.g., EV, DV, BV)
* ECOG performance status 0-2
* No baseline peripheral neuropathy ≥ Grade 1 (CTCAE v5.0)
* Stable tumor status without other neurotoxic drugs in the past 2 months
* Adequate organ function (blood counts, liver and kidney function) per protocol
* Expected survival ≥ 3 months
* Ability and willingness to comply with study procedures and provide written informed consent
Exclusion Criteria:
* Poor compliance or inability to follow protocol
* Pre-existing peripheral neuropathy ≥ Grade 1 from prior platinum/taxane treatment
* Severe diabetes or peripheral vascular disease
* Neurological disorders causing nerve compression (e.g., carpal tunnel syndrome, radiculopathy)
* Severe psychiatric conditions (depression, bipolar disorder, substance abuse)
* Active uncontrolled infections requiring systemic antibiotics/antifungals/antivirals (≥ CTCAE Grade 2)
* Active hepatitis or significant liver dysfunction not meeting inclusion criteria
* Renal failure requiring dialysis
* Immunodeficiency or history of organ transplantation
* Severe nausea, headache, fatigue, or other debilitating symptoms
* Active tuberculosis or uncontrolled pleural/pericardial effusion/ascites
* Hypersensitivity to monoclonal antibodies or study device components
* Participation in other clinical trials within 4 weeks
* Known bleeding or coagulation disorders or receiving thrombolytic therapy
* Any other condition judged by the investigator to preclude safe participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07164950
Study Brief:
Protocol Section:
NCT07164950