A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies

Contact:

NCT Number:

Protocol:

ACYY0017

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

Treatments for B cell cancers that return or are hard to treat often do not last long. Even when patients improve at first, the cancer usually comes back. Drugs called Bruton’s tyrosine kinase (BTK) inhibitors have helped people with conditions such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), marginal zone lymphoma (MZL), and follicular lymphoma (FL). However, these drugs cannot fully stop the disease, because cancer cells can change and resist treatment. This study is testing BGB 16673, an oral drug that breaks down BTK, a protein that helps these cancers grow. BGB 16673 is still being studied and has not been approved by the United States Food and Drug Administration (FDA). The trial will evaluate BGB 16673 together with other drugs. All of the combination drugs are FDA approved, including zanubrutinib, obinutuzumab, mosunetuzumab, glofitamab, and sonrotoclax. The goal is to see whether combining BGB 16673 with these drugs can help patients keep their cancer under control for longer than current treatments.

Are you Eligible? (Inclusion Criteria)

  • older than 18 years of age - confirmed diagnosis of a R/R B-cell malignancy - must have measurable disease

Specialty Area(s)

Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, Immunotherapy

Principal Investigator

Trial Location(s)

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