RECRUITING

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts)

Official Title

A Phase 1/2, Open-Label, Dose-Escalation and -Expansion Study of the Bruton Tyrosine Kinase Targeted Protein Degrader BGB-16673 in Patients With B-Cell Malignancies

Quick Facts

Study Start:2021-09-13
Study Completion:2028-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05006716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Prior malignancy (other than the disease under study) within the past 2 years, except in situ malignancies that have been curatively resected, localized breast cancer treated with curative intent with no evidence of breast active disease for more than 3 years and receiving adjuvant hormonal therapy, localized Gleason score ≤ 6 prostate cancer undergoing observation or treatment with androgen depravation, or any other cancer treated with curative intent, not on adjuvant treatment, and in the opinion of the investigator is unlikely to recur.
  2. 2. Requires ongoing systemic treatment for any other malignancy
  3. 3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
  4. 4. Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether participants had received treatment for central nervous system disease
  5. 5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, germinal center B-cell (GCB), DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected transformation of an indolent lymphoma to an aggressive histology (except for participants with Richter Transformation to DLBCL are eligible for Part 1a, 1c, or Phase 2 and participants with history of follicular lymphoma transforming to non-GCB DLBCL who are eligible for Part 1a, 1c, or Phase 2).

Contacts and Locations

Study Contact

BeiGene
CONTACT
1.877.828.5568
clinicaltrials@beigene.com
Study Director, MD
CONTACT

Study Locations (Sites)

University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294
United States
Mayo Clinic Phoenix
Phoenix, Arizona, 85254
United States
University of Arizona Cancer Center
Tucson, Arizona, 85724
United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, 92037
United States
UCLA Santa Monica Cancer Care
Santa Monica, California, 90404
United States
Stanford Medicine
Stanford, California, 94305
United States
Uchealth North
Fort Collins, Colorado, 80528
United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
United States
Tampa General Hospital Cancer Institute
Tampa, Florida, 33606
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Norton Cancer Institute Pavilion
Louisville, Kentucky, 40207
United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York, 10021
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065
United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203
United States
Md Anderson Cancer Center
Houston, Texas, 77030
United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: BeiGene

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-13
Study Completion Date2028-03-31

Study Record Updates

Study Start Date2021-09-13
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • B-cell Malignancy
  • Marginal Zone Lymphoma
  • Follicular Lymphoma
  • Non-Hodgkin Lymphoma
  • Waldenström Macroglobulinemia
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Diffuse Large B Cell Lymphoma