A Phase I, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS5001, an Anti-ROR1 Antibody Drug Conjugate, in Patients with Advanced Solid Tumors and Lymphomas

Contact:

NCT Number:

Protocol:

AAAU0306

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I

This is a study of the experimental drug CS5001 developed by CStone pharmaceutical, in patients with advanced hematological and solid tumors. CS5001 will target certain receptors that are in high levels on cancer cells. This study will look at the anti-tumor activity of CS5001. CS5001 is not approved by any regulatory agency for the treatment of any condition. It is only available in clinical studies such as this one. To date, it has only been tested in animal studies. This is the first time that the study drug will be given to humans.

Are you Eligible? (Inclusion Criteria)

  • Are you at least 18 years old? -Have you progressed on or been intolerant to available standard of care therapies? -You do not have a diagnosis of immunodeficiency, or have an active autoimmune disease or other conditions that require systemic steroid therapy? You are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures?

Specialty Area(s)

Bladder Cancer , Breast Cancer, Colon and Rectal Cancer, Esophageal Cancer, Gynecologic Cancers, Cervical Cancer, Ovarian Cancer, Head and Neck/Oral Cancers, Kidney Cancer/Adrenal Cancer, Leukemia, Liver Cancer, Lung cancer, Hodgkin's Disease, Non-Hodgkin's Lymphoma, Pancreatic Cancer, Prostate Cancer, Stomach Cancer, Testicular Cancer

Principal Investigator

Trial Location(s)

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