Urothelial carcinoma
Conditions
Interventions
MRG003:Vibekototumab (MRG003): 2.3 mg/kg, IV drip, day 1, every 3 weeks.
Treat until the disease relapses or progresses, or until intolerable toxicity occurs.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ,: - "1.""2."; - (9)"(1)""(2)"; - :"="">=","=""= 18 years. 3. Histopathologically confirmed pure urothelial squamous cell carcinoma or urothelial carcinoma with squamous differentiation (squamous component > 70%) by the Department of Pathology of our hospital; primary tumor sites include the renal pelvis, ureter, bladder, or urethra (pathological staging according to the AJCC TNM Staging Manual, 8th Edition). 4. Patients with pathologically confirmed unresectable locally advanced (T4N0M0 or TxN1-3M0) or metastatic (TxNxM1) urothelial squamous cell carcinoma (first-line or above). 5. Availability of tumor paraffin-embedded tissue blocks for EGFR immunohistochemistry (IHC) and other assays (EGFR IHC testing will be independently performed and interpreted by the Department of Pathology, Sun Yat-sen University Cancer Center). 6. Ineligibility for radical surgical resection, or presence of distant metastatic lesions (M1). 7. Presence of measurable disease according to RECIST version 1.1. 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and an expected survival time >= 6 months. 9. Organ and hematopoietic function meeting the following requirements: (1) Hemoglobin (HGB) >= 80 g/L; (2) White blood cell count (WBC) >= 3 x 10^9/L; (3) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; (4) Platelet count (PLT) >= 80 x 10^9/L; (5) Total bilirubin = 30 mL/min.
Exclusion criteria
Exclusion criteria: 1. Histopathological evidence of small cell/neuroendocrine differentiation or sarcomatoid differentiation. 2. Eligibility for radical resection and patient tolerance of radical surgery. 3. Prior treatment with MMAE-containing anti-tumor agents. 4. Presence of severe medical conditions, such as severe infection, uncontrolled diabetes, cardiovascular diseases (NYHA Class III or IV heart failure, atrioventricular block >= Grade II, myocardial infarction within the past month, unstable arrhythmias, or unstable angina), or severe pulmonary diseases (interstitial pneumonia, severe obstructive pulmonary disease, or a history of symptomatic bronchospasm); or a history of symptomatic liver, kidney, hematological, endocrine, neurological, or psychiatric disorders. 5. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV-1/2 antibodies). 6. Active hepatitis B requiring treatment. However, subjects meeting the following criteria are eligible: HBV DNA viral load must be < 1000 copies/mL (200 IU/mL) prior to the first dose. Subjects must receive anti-HBV therapy throughout the study chemotherapy period to prevent viral reactivation. Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV DNA (-) do not require prophylactic anti-HBV therapy but need close monitoring for viral reactivation. 7. Receipt of live vaccines within 30 days prior to the first administration (Cycle 1, Day 1). Note: Inactivated influenza vaccines administered via injection are permitted within 30 days prior to the first dose; however, intranasal attenuated live influenza vaccines are prohibited. 8. Concurrent active malignancy or a history of other malignancies within the past five years, except for: (1) Cured non-melanoma skin cancer; (2) Curatively treated tumors including cervical carcinoma in situ and superficial bladder cancer; (3) Other solid tumors that have undergone radical treatment with no recurrence or metastasis for 5 years or longer. 9. History of definite neurological or psychiatric disorders, such as epilepsy or dementia, or poor compliance. 10. History of drug abuse or substance dependence. 11. Other severe, acute, or chronic medical conditions or abnormal laboratory findings that might increase the risk associated with study participation or investigational product administration, or interfere with the interpretation of study results. 12. Deemed unsuitable for participation in the study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Overall Survival;Progression-Free Survival;Quality of Life;Treatment Emergent Adverse Event Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactKai Yao
Sun Yat-sen University Cancer Center
Outcome results
None listed