Phase
Condition
Urothelial Carcinoma
Bladder Cancer
Carcinoma
Treatment
9MW2821
Toripalimab (JS001 )
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Voluntary participation
Age 18-80
ECOG 0-1
Histologically confirmed inoperable locally advanced or metastatic urothelialcarcinoma (including bladder, renal pelvis and ureter). Mixed histology withsquamous or adenomatous differentiation is allowed if urothelial carcinomadifferentiation is >50%.
Has not received any systemic treatment for locally advanced or metastaticurothelial carcinoma
At least 1 measurable target lesion that satisfies RECIST v1.1 definition. If thepatient has received radiotherapy, the target lesion needs to be outside theradiation field or has demonstrated clear progression after radiotherapy.
Life expectancy over 12 weeks
Appropriate hematological and organ functions
Agree to contraceptive measures until 180 days after the last dose of study drugadministration
Able to understand and follow study visits, treatment, laboratory assessment andother procedures
Exclusion
Exclusion Criteria:
Other concurrent malignancy within 3 years prior to randomization
Active autoimmune disease requiring systemic treatment within 2 years prior torandomization. Having received high dose corticosteroid (>10mg/day prednisoloneequivalent) or other immunosuppressive agents.
Severe cardiovascular or cerebral vascular thrombo-embolic events within 6 monthsprior to randomization
Major surgery within 28 days prior to randomization, except for minor proceduresthat the PI considers not to impact study participation. Live vaccine within 28 daysprior to randomization or planning to take live vaccine during the study.Radiotherapy or bladder infusion therapy within 21 days prior to randomization. Useof strong CYP3A4 inhibitors within 14 days prior to randomization.
Lung effusion or ascites that require treatment within 14 days prior torandomization. Cancer-related severe uncontrolled bone pain or spinal cordcompression within 14 days prior to randomization. Active infection that requiressystemic antibiotic treatment within 7 days prior to randomization.
Have received prior treatment with anti-PD-1, anti-PD-L1/PD-L2 or anti-CTLA-4therapies. Have received prior treatment with Nectin-4 targeted therapy or ADC withMMAE as payload. Have received allogeneic hematological stem cell transplantation orsolid organ transplant.
Toxicities from previous cancer treatment (radiotherapy, chemotherapy or surgery)that have not recovered to grade 0-1 according to CTCAE v5.0, except for alopeciaand skin hyperpigmentation.
Severe dry eyes, active keratitis, corneal ulceration or other risk factors forcorneal diseases where the PI judges to be not suited for this study
Preexisting grade ≥ 2 neuropathy prior to randomization
Other uncontrolled serious illness
Brain metastasis or meningeal carcinomatosis
HBsAg positive, and HBV-DNA copy number positive ; HCV-Ab positive and HCV-RNApositive; HIV-Ab positive
Known allergy to the study drug or components of the study drug
Drug abuse or psychiatric disorder that would impact study compliance
Other circumstances that the PI judges to be not suitable for the study
Study Design
Connect with a study center
Beijing Chao-yang Hospital, Capital Medical University
Beijing, Beijing
ChinaSite Not Available
Fujian Medical University Union Hospital
Fuzhou, Fujian
ChinaSite Not Available
Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
ChinaSite Not Available
Hunan Tumor Hospital
Changsha, Hunan 410013
ChinaActive - Recruiting
Jiangsu People's Hospital
Nanjing, Jiangsu
ChinaSite Not Available
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210000
ChinaActive - Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
ChinaSite Not Available
Shao Yi Fu Hospital
Hangzhou, Zhejiang
ChinaSite Not Available
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