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

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The purpose of this study is to measure the safety, preliminary antitumor activity, pharmacokinetics, and pharmacodynamics with BGB-16673 in combination with other agents in participants with relapsed or refractory (R/R) B-cell malignancies. This study is structured as a master protocol with separate substudies. This study currently includes four substudies, and more substudies may be added as other combination agents are identified.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF

• Confirmed diagnosis of a R/R B-cell malignancy

• Protocol-defined measurable disease

• Stable Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2

• Adequate organ function

• Female participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab. A negative urine or serum pregnancy test result must be provided 10-14 days before the first dose of study treatment

• Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 30 days after the last dose of BGB-16673 or zanubrutinib, 60 days after the last dose of glofitamab, or 90 days after the last dose of sonrotoclax or mosunetuzumab

• Substudies 1, 3, and 4 Inclusion Criterion:

‣ Adequate renal function as indicated by estimated glomerular filtration rate (eGFR) of ≥ 50 mL/min

• Substudy 2 Inclusion Criteria:

‣ Bruton tyrosine kinase (BTK) inhibitor-naive, or previously received treatment with a covalent BTK inhibitor and discontinued for reasons other than clinical progression

⁃ Adequate renal function as indicated by eGFR of ≥ 30 mL/min

Locations
United States
Arizona
Mayo Clinic Phoenix
RECRUITING
Phoenix
California
University of Southern Californianorris Comprehensive
RECRUITING
Los Angeles
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Moffitt Cancer Center
RECRUITING
Tampa
Kansas
The University of Kansas Cancer Center
RECRUITING
Westwood
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New Jersey
Summit Medical Group
RECRUITING
Florham Park
New York
Icahn School of Medicine At Mount Sinai
RECRUITING
New York
Memorial Sloan Kettering Cancer Center Mskcc
RECRUITING
New York
Weill Cornell Medical College Newyork Presbyterian Hospital
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Texas
The University of Texas Md Anderson Cancer Center
RECRUITING
Houston
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Wisconsin
University of Wisconsin
RECRUITING
Madison
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Monash Health
RECRUITING
Clayton
St George Hospital
RECRUITING
Kogarah
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Linear Clinical Research
RECRUITING
Nedlands
Mater Cancer Care Centre
RECRUITING
South Brisbane
China
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Sun Yat Sen University Cancer Center
RECRUITING
Guangzhou
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
RECRUITING
Hangzhou
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Italy
Centroricerche Cliniche Di Verona Srl
RECRUITING
Verona
New Zealand
Auckland City Hospital
RECRUITING
Auckland
North Shore Hospital
RECRUITING
Auckland
Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
RECRUITING
Warsaw
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
1.877.828.5568
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2029-12-02
Participants
Target number of participants: 80
Treatments
Experimental: Substudy 1 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Experimental: Substudy 1 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and sonrotoclax will be evaluated in participants with selected B-cell malignancies.
Experimental: Substudy 2 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Experimental: Substudy 2 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and zanubrutinib will be evaluated in participants with selected B-cell malignancies.
Experimental: Substudy 3 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Experimental: Substudy 3 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and mosunetuzumab will be evaluated in participants with selected B-cell malignancies.
Experimental: Substudy 4 Part 1a: Dose Escalation
Sequential cohorts of increasing dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies. Participants will receive obinutuzumab as pretreatment prior to the start of combination treatment.
Experimental: Substudy 4 Part 1b: Safety Expansion
Cohorts of select dose level combinations of BGB-16673 and glofitamab will be evaluated in participants with selected B-cell malignancies.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines

This content was sourced from clinicaltrials.gov

Similar Clinical Trials