Metastatic Urothelial Cancer Clinical Trial
Official title:
A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer
The objectives of this study are to assess the safety, pharmacokinetics, immunogenicity and anti-tumor activity of AGS15E in subjects with metastatic urothelial cancer who failed at least one prior chemotherapy regimen for metastatic disease.
All subjects will receive a single intravenous infusion of AGS15E once weekly for 3 weeks of
every 4 weeks. A cycle is 4 weeks. Subjects will continue treatment until disease
progression, intolerability of AGS15E, investigator decision, or consent withdrawal.
In subjects who discontinue therapy without documented disease progression and who still
consent to study procedures, every effort should be made to continue monitoring their disease
status by radiographic imaging until progression is documented, or new anticancer therapy, or
death. All subjects will continue to be followed for survival until withdrawal of consent or
study closure.
If assessed as complete response (CR) or partial response (PR) per local review a
confirmatory scan will be performed no less than 4 weeks from previous scan and preferably at
week 5. Tumor imaging should also be performed whenever disease progression is suspected.
Images will be sent to a central third party imaging vendor for an independent assessment per
RECIST version 1.1. Although the imaging studies will be reviewed by a central third party
imaging vendor in a retrospective fashion, all clinical decisions will be based on the
interpretation of the investigator at the site treating the subject.
Post-Treatment Follow-up Progression Free Survival:
Subjects who discontinued study treatment for reasons other than radiographic disease
progression will continue for a maximum of up to 12 months following the last dose of study
drug until radiologically confirmed progression, initiation of a new anticancer therapy,
death, loss to follow-up or withdraw consent for further follow-up, whichever of these events
occurs first. The purpose of the post-treatment follow-up is to ascertain the duration of
progression-free survival for all subjects enrolled in the study.
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