Phase 1/2 Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT7480 in Patients With Nectin-4 Associated Advanced Malignancies

Contact:

NCT Number:

Protocol:

AAAU0713

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

The purpose of this study is to evaluate whether the investigational drug, BT7480, will be a safe and effective anticancer therapy. This is the first time BT7480 will be given to humans. BT7480 is designed to recognize and attach itself to both the Nectin-4 protein found on the surface of some cancer cells and CD137, a protein found on the surface of some immune cells. BT7480 binds to both Nectin-4 and CD137 and may activate immune cells to fight the Nectin-4- expressing cancers.

Are you Eligible? (Inclusion Criteria)

  • Must be aged 18 years or older.
  • Must have locally advanced or metastatic disease that cannot be treated with standard therapy.
  • Must have a confirmed diagnosis of malignant solid tumor associated with Nectin-4 expression, including urothelial (transitional cell) carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; and ovarian, breast, gastric, or esophageal carcinoma.

Specialty Area(s)

Bladder Cancer , Breast Cancer, Esophageal Cancer, Ovarian Cancer, Head and Neck/Oral Cancers, Lung cancer, Stomach Cancer, Immunotherapy

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032