Protocol
11-113
Full Title
A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS-22M6E Given as Monotherapy Followed by Expansion Cohorts in Subjects with Malignant Solid Tumors that Express Nectin-4
Purpose
Nectin-4 is a protein produced by some cancers. Bladder, breast, pancreas, lung, and ovarian cancers frequently produce Nectin-4.
AGS-22M6E is an investigational drug that is designed to attach to Nectin-4 on the surface of cancer cells and then poison the cell. The purpose of this study is to find the highest dose of AGS-22M6E that can be given safely in patients with malignant solid tumors that produce Nectin-4.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a malignant solid tumor that expresses Nectin-4. Interested patients will have their tumors tested for Nectin-4.
- The tumor must have persisted or returned despite prior therapy or have no standard therapy.
- At least 4 weeks must have passed since completion of prior therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- Patients must be age 18 or older.
For more information about this study, please contact Dr. Jason Konner at 646-888-4219.
Locations
