A Phase II Study of ASP1650 for Men with Incurable Germ Cell Tumors

Share
Print

Full Title

A Phase 2, Open-Label, Single-Arm, Multicenter Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects with Incurable Platinum Refractory Germ Cell Tumors

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug ASP1650 in men with germ cell tumors, such as testicular cancer, that have come back or continued to grow despite chemotherapy that included platinum-containing drugs, such as cisplatin. ASP1650 works by targeting Claudin-6 (CLDN6), a protein that is often seen in germ cell cancers but rarely in normal cells. ASP1650 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 a germ cell tumor, including seminomas and non-seminomas, that came back or continued to grow despite platinum-containing chemotherapy. The tumor could have started in the testis (testicular cancer) or outside of the testis.
  • Patients should recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for men age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Darren R. Feldman at 646-888-4740.

Protocol

19-175

Phase

II

Investigator

Co-Investigators