Klinische Studie

A Phase II Open Label, Study of IMMU-132 in Metastatic Urothelial Cancer After Failure of Platinum-Based Regimen or Anti-PD-1/PD-L1 Based Immunotherapy(IMMU-132-06)A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
Krankheitsentität(en) Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase II
Wesentliche Einschlusskriterien1) Female or male subjects, ≥ 18 years of age, able to understand and give written informed consent. 2) Subjects with histologically documented locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV) UC. Upper and lower tract tumors are permitted and mixed histologies are permitted if UC is the predominant histology. 3) Cohorts 4, 5, and 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma must be provided for biomarker testing including PD-L1 and Trop-2. 4) Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1. 5) Cohort 1: Have had progression or recurrence of UC following receipt of platinum-containing regimen (cisplatin or CARBO): a) Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease; b) Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive UC, with recurrence/progression ≤12 months following completion of therapy.
Wesentliche Ausschlusskriterien1) Women who are pregnant or lactating. 2) Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of trial treatment. 3) Has a diagnosis of immunodeficiency. 4) Has had a prior anticancer mAb within 4 weeks prior to study Day 1 or who has not recovered (ie, ≤Grade 1) from AEs due to agents administered more than 4 weeks earlier. 5) Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (ie, ≤Grade 1 from AEs due to a previously administered agent). However, for Cohort 5: Alopecia, sensory neuropathy Grade ≤2 is acceptable, or other Grade < 2 adverse events not constituting a safety risk based on the investigator’s judgment are acceptable.
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de