Condition: Urothelial Carcinoma, Advanced Solid Tumors, Chemotherapy-Induced Peripheral Neuropathy, Antibody-drug Conjugates

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT07164950

Sponsor: Sheng Zhang

Eligibility:

• Age: minimum 18 Years maximum 75 Years
• Gender: All

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

View trial on ClinicalTrials.gov