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
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.
Statusrekrutierend
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de