Brief Title
Treatment of Chinese Patients With B-Cell Malignancies With BGB-16673, a Burton Tyrosine Kinase-Targeted Protein-Degrader
Official Title
A Phase 1, Open-Label, Dose-Escalation and Expansion Study of the Bruton Tyrosine Kinase Targeted Protein-Degrader BGB-16673 in Chinese Patients With B-Cell Malignancies
Brief Summary
This study aims to explore the recommended phase 2 dose and evaluate the safety, tolerability and preliminary antitumor activity of BGB-16673 monotherapy at the recommended Phase 2 dose for the selected B-cell malignancy expansion cohorts
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of participants with adverse events (AEs)
Secondary Outcome
Maximum observed plasma concentration (Cmax) of BGB-16673
Condition
B-cell Malignancy, Low-grade
Intervention
BGB-16673
Study Arms / Comparison Groups
Part 1 (Dose Finding)
Description: BGB-16673 will be orally administered
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
76
Start Date
March 24, 2022
Completion Date
March 2027
Primary Completion Date
March 2027
Eligibility Criteria
Key Inclusion Criteria 1. Provision of signed and dated written informed consent prior to any study, Age ≥ 18 years 2. ECOG Performance Status of 0 to 2 3. Adequate organ function of coagulation function, liver function, renal function and pancreatic function and measure disease per disease-specific response criteria 4. Confirmed diagnosis of R/R MZL, FL (grade 1-3a), MCL, CLL/SLL, WM and previously treated 5. Highly effective method of birth control during study treatment period, and for at least 90 days after the last dose of the study drug Key Exclusion Criteria 1. Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer 2. Require ongoing systemic treatment for any other malignancy or systemic corticosteroid treatment 3. Receiving treatment with a strong CYP3A inhibitor or inducer, or proton-pimp inhibitors ≤ 14 days before the first dose of BGB-16673. 4. Current or history of central nervous involvement 5. Prior autologous stem cell transplant unless ≥ 3 months after transplant, prior chimeric cell therapy unless ≥ 6 months after cell infusion, prior allogeneic stem cell transplant ≤ 6 months before the first dose of the study drug Note: Other protocol defined Inclusion/Exclusion criteria may apply
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 1.877.828.5568, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05294731
Organization ID
BGB-16673-102
Responsible Party
Sponsor
Study Sponsor
BeiGene
Study Sponsor
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Verification Date
April 2022