Urothelial Carcinoma
Conditions
Interventions
Trial Group:Lukangsatuzumab 5 mg/kg, intravenous infusion, administered once every 2 weeks
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (if mixed histology is present, the urothelial component shall be >50% and the plasmacytoid component 18 years, either gender. 3. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1), and the measurable lesion has not received local treatment such as radiotherapy. 4. Failure of prior treatment with vintafoltil, disitamab vedotin, or other ADCs with targets and payloads different from those of the study drug; subjects who relapse within 6 months after completion of neoadjuvant/adjuvant chemotherapy shall be considered to have failed first-line treatment and may be enrolled if the regimen was an ADC or immunotherapy combined with an ADC. 5. Life expectancy >= 12 weeks. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to dosing. 7. Radiological disease progression occurred during or after the most recent treatment for locally advanced or metastatic disease. 8. Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows: (1) Hematology: absolute neutrophil count (NEUT#) >= 1.5×10^9/L; platelet count (PLT) >= 100×10^9/L; hemoglobin >= 9 g/dL; (2) Hepatic function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) = 60 mL/min. 9. Voluntary participation in this study, signed informed consent, good compliance, and willingness to comply with follow-up requirements.
Exclusion criteria
Exclusion criteria: 1. Subjects who have received chemotherapy or other therapeutic regimens after failure of vintafoltil, disitamab vedotin, or other ADC treatments. 2. Subjects with known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, active or untreated central nervous system (CNS) metastases. Subjects with previously locally treated brain metastases may be enrolled if clinically stable for at least 4 weeks before dosing and do not require glucocorticoids or anticonvulsants for at least 14 days. 3. Prior treatment with TROP2-targeted therapy; prior treatment with any topoisomerase I inhibitor and chemotherapy. 4. Uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite optimal medical therapy). 5. Presence of persistent or active infection. 6. Participation in another clinical trial of anti-tumor agents within 4 weeks prior to screening. 7. Presence of adverse events > CTCAE Grade 1 prior to the first dose (excluding alopecia and endocrine toxicity). 8. Presence of other unresolved malignancies within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix). 9. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulceration, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding. 10. Active hepatitis B or hepatitis C infection. 11. Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 12. Known hypersensitivity to the study drug or any of its components. 13. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroids, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening. 14. Clinically significant pulmonary impairment due to concurrent lung diseases, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion within 3 months prior to dosing) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc.), or prior pneumonectomy. 15. Uncontrolled diabetes mellitus (fasting blood glucose >= 10 mmol/L on two consecutive occasions). 16. Presence of clinically symptomatic or repeatedly drained pleural effusion, pericardial effusion, or ascites (> 1 episode/week). 17. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that impairs delayed corneal healing. 18. Any condition that, in the investigator’s opinion, interferes with the evaluation of the study drug or subject safety or interpretation of study results, or any other condition for which the investigator considers the subject unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Progression-Free Survival (PFS);Overall Survival (OS);Duration of Response (DOR); | — |
Countries
China
Contacts
Public ContactCao Baoshan
Peking University Third Hospital
Outcome results
None listed