A Phase I Study of ASG-22CE in Patients with Metastatic Urothelial Cancers Containing Nectin-4

Full Title

A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of ASG-22CE Given as Monotherapy in Subjects with Metastatic Urothelial Cancer and Other Malignant Solid Tumors that Express Nectin-4

Purpose

About 65 percent of bladder cancers have high levels of a protein called Nectin-4. ASG-22CE is an investigational drug designed to treat cancers containing this protein. ASG-22CE is composed of an antibody that targets Nectin-4, attached to an anticancer drug that can kill cancer cells containing this protein.

In this study, researchers want to determine the highest dose of ASG-22CE that can be given safely in patients with metastatic urothelial (bladder, urethra, ureter, or renal pelvis) cancers that have continued to grow despite prior therapy and contain high levels of Nectin-4. ASG-22CE is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic transitional cell urothelial (bladder, urethra, ureter, or renal pelvis) cancer that has continued to grow despite prior therapy, or patients must not be able to receive cisplatin-based chemotherapy.
  • Patients’ cancers must contain high levels of the Nectin-4 protein.
  • At least 2 weeks must have passed since the completion of prior therapy and entry into the study, and patients must have recovered from any serious side effects.
  • 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.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Jonathan Rosenberg at 646-422-4461.

Protocol

14-108

Phase

I

Investigator

Co-Investigators

Locations