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A Phase 1, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase-Targeted Protein-Degrader BGB-16673 in Patients With B-Cell Malignancies

Clinical Trial Details

The purpose of this study is to test the safety and tolerability of an experimental anticancer drug currently known as BGB-16673 for men and women who have B-cell malignancies.

Experimental means that it has not yet been approved by the US Food and Drug Administration (FDA).

BGB-16673 is an oral Bruton tyrosine kinase (BTK) targeted protein degrader, which targets and binds to BTK in the body, inhibiting its activity. BTK in the body allows malignant cells to survive and BTK inhibitors interfere with this process.

Participants will join either the dose finding phase of the study or the dose expansion phase of the study. During the dose finding phase, a small group of participants will be given the smallest planned dose of BGB-16673. If this dose is tolerated well by the participants, the next cohort of participants will receive a slightly higher dose of BGB-16673. The study team will let participants know in which phase of the study they are participating and what dose they will receive.
   
Participation in this research will last about 2 years, but may vary based on how participants respond to the study drug.

Key Eligibility: 
  1. Over the age of 18
  2. Confirmed diagnosis of a B-cell malignancy such as marginal zone lymphoma (MZL), follicular lymphoma (FL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Waldenstrom macroglobulinemia (WM), diffuse large B cell lymphoma (DLBCL), or the Richter's transformation to DLBCL.

Detailed eligibility will be reviewed when participants contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Katie Greig
212-746-6738
kag9156@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2203024637

ClinicalTrials.gov:

NCT05006716

Sponsor:

BGB-16673-101

Status

Open to Enrollment

Age Group

Adult

Sponsor